MAUDE Adverse Event Report: COOK INC CODA LP BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number N/A

Device Problems Inflation Problem (1310); Material Rupture (1546); Inadequacy of Device Shape and/or Size (1583); Lack of Effect (4065)

Patient Problem Necrosis (1971)

Event Date 07/26/2022

Event Type  malfunction  

Event Description

It was reported a coda lp balloon catheter had to be changed during an organ donation procedure.The balloon was being used as an obstructive balloon on the aorta during placement of ecmo for an organ donation procedure classified as maastricht category 3.Despite correct positioning of the balloon confirmed through radiography, cardiac activity restarted.Recoloration was noted and saturation was 80%.Ecmo flow rate was 4.5l/m.The balloon had to be changed and the procedure had to be stopped.The organ donation was lost.The customer reported two devices of the same lot, however, at this time its unclear if/how the second device failed.No other adverse effects were reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Customer contact information phone:(b)(6).Fax: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

In additional information, it was reported that the procedure was a maastrich 3 organ donation procedure (people who died of cardiac arrest after scheduled discontinuation of therapy).After declaration of death, extracorporeal membrane oxygenation (ecmo) cannulation was performed without difficulty and normothermic regional circulation was established according to usual procedures.Then the patient was connected to the ecmo system with a coda balloon in the aorta to prevent reperfusion of the brain and heart; however, the patient had a resumption of electrical activity, then cardiac activity, and oxygen saturation increased to 80%.Skin recoloration was also observed in the upper part of the body.It was noted that positioning from the balloon to the control radio was correct and ecmo flow was 4.5l/m.The user then attempted to change the balloon; however, supra-diaphragmatic vascularization persisted, so the procedure was stopped and the grafts were lost.

Event Description

Two devices were returned to cook for evaluation.The first balloon was returned ruptured circumferentially.The second balloon catheter had no damage.It is unknown if the second balloon was used or how/if it failed.Additional information regarding the event has been requested but is currently unavailable.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

In additional information, it was reported that the intra-aortic balloon is recommend to be placed at the sub-diaphragmatic level "at the pose" because normal thermal regional circulation concerns only the sub-diaphragmatic organs for the moment.The diameter of the patient's descending aorta at the intended occlusion location was 24mm.A coda 32 balloon was obtained and placed in the aorta by the surgeon, but occlusion was not achieved ("despite the positioning control on the rp").The balloon was further inflated.Then, an additional coda 32 balloon was obtained but, again, occlusion was not achieved.As a result, the deceased patient showed resumption of electrical activity, then cardiac activity, and a progressive increase in saturation.On the patient's computed tomography (ct) scan, no anatomical variant was present that could explain the situation.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Additional information: b5 this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation: c.H.G.De dijon informed cook on 26jul2022 of an event involving coda lp balloon catheter (rpn: coda-2-9.0-35-120-32, product lot: 14762377).It was reported during the placement of the ecmo during an organ donation procedure (maastricht 3) the physician was unable to occlude the vessel with coda balloon and the balloon ruptured.The balloon had to be changed and the procedure was stopped, resulting in loss of the organ donation.Reviews of the documentation, including the complaint history, device history record, specifications, drawings, instructions for use (ifu), manufacturing instructions (mi), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.Two used devices were returned for evaluation.Upon visual inspection of balloon catheter #1, the balloon was found to be ruptured circumferentially.The marker bands were intact and measured within specification.For balloon catheter #2, there was no damage noted.When inflated and submerged both in and out of water, no leaks or ruptures were noted.The marker bands were intact and measured within specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for product lot 14762377 revealed three nonconformances reported; however, they were re-worked and re-inspected prior to further processing.There was one other complaint associated with this product lot regarding this event.It should be noted that no other complaints were associated with the final product lot number.Cook also reviewed product labeling.The device was packaged with ifu t_codalp_rev3.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.Warnings ¿ do not exceed maximum inflation volume.Adhere to balloon inflation parameters as shown in fig.1.Over-inflation of balloon may result in: o damage to vessel wall and/or vessel rupture.O rupture of balloon.¿ do not use a pressure inflation device for balloon inflation.¿ do not use a power injector for injection of contrast medium through distal lumen.Rupture may occur.¿ the coda 40 mm balloon catheter should not be used for dilation of vascular prostheses in iliac or other non-aortic vessels.Injury to vessel wall and/or rupture may occur.¿ the coda 40 mm balloon catheter should not be used in vessels less the 24 mm diameter.Potential adverse events ¿ vessel dissection, perforation, rupture, or injury balloon inflation volume do not exceed maximum inflation volume.Adhere to balloon inflation parameters as shown in fig.1.Over-inflation of balloon may result in: ¿ damage to vessel wall and/or vessel rupture.¿ rupture of balloon.Maximum inflation volumes catheter size max.Volume coda-2-10.0-35-120-40 40 cc coda-2-9.0-35-100-32 30 cc coda-2-9.0-35-120-32 30 cc balloon introduction and inflation ¿ caution: prior to introduction, determine the amount of standard 3:1 saline and contrast mixture needed to inflate the balloon to the desired inflation diameter.Refer to the balloon inflation parameters chart in fig.1.Over-inflation of the balloon may result in damage to vessel wall and/or vessel rupture.¿ if balloon pressure is lost and/or balloon rupture occurs, deflate the balloon, and remove balloon and sheath as a unit.Note: care should be taken to monitor balloon manipulations and inflation using fluoroscopy at all times.After review of the ifu, cook has concluded the device labeling contains appropriate warnings, precautions and instructions to the user related to the reported failure.Evidence provided by the complaint facility, dhr, device failure analysis, complaint history, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Based on the information provided, examination of the returned product and the results of our investigation, cook has determined that a definitive conclusion could not be determined.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Additional information: e4, h6 - annex a.Correction: b1, b2, h1.B1, b2, h1: the device was used in a patient that was determined to be clinically dead before the procedure began.The loss of organ harvest is not considered to be a serious injury to the patient in which the device was used.This event is now reportable under fda 21 cfr part 803 as it meets the criteria for a reportable product malfunction.Investigation-evaluation: c.H.G.D dijon, dijon, france reported to cook that two cook coda balloon catheters used in a maastrich 3 organ donation procedure were not able to occlude the patient¿s aorta.The patient was a 70-year-old male who weighed 75 kilograms.The patient underwent a maastrich 3 organ donation procedure on (b)(6) 2022 after the declaration of death, placement of cannulations was completed without difficulty.The establishment of normothermic region circulation for the sub-diaphragmatic organs required an intra-aortic occlusion.The intended location for the intra-aortic occlusion was the sub-diaphragmatic level.The area was reported to be 24 mm in diameter.The cook coda lp balloon catheter (rpn: coda-2-9.0-35-120-32, lot 14762377) was advanced into the aorta.However, despite positioning control via radiography, occlusion could not be achieved.Cardiac activity resumed, as well as recoloration.The patient¿s oxygen saturation returned to 80%.Ecmo flow at the time of revascularization was reported to be 4.5l/m.In an effort to continue to try and occlude the aorta, the surgeon inflated the cook coda lp balloon catheter a little more (exact amount unknown).The first cook coda lp balloon catheter was removed, and another cook coda lp balloon catheter (rpn: coda-2-9.0-35-120-32, lot 14762377) was advanced, but was also not able to occlude the aorta.As a result supra-diaphragmatic vascularization continued.The organ donation was not able to be completed and a loss of grafts were reported.It was reported that on the patient's computed tomography (ct) scan there were no anatomical variants that could explain why the cook coda lp balloon catheter could not occlude the aorta.Reviews of documentation including the complaint history, drawing, device history record (dhr), quality control, specifications, manufacturing instructions (mi), instructions for use (ifu), as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (14762377) and the related subassembly lots revealed three related non-conformances, but they were reworked and re-inspected prior to further processing.A database search identified two complaints against this product lot number.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.The two used complaint devices were returned to cook for investigation.The cook coda lp balloon catheter that was used first during the procedure was discovered to be ruptured circumferentially.The radiopaque marker bands were intact and measured within specification.The second cook coda lp balloon catheter revealed no balloon leaks when inflated.No leaks in the balloon were detected when the device was submerged under water.No material rupture or damage was identified.The radiopaque marker bands were intact and measured within specification.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: warnings do not exceed maximum inflation volume.Adhere to balloon inflation parameters as shown in fig.1.Over-inflation of balloon may result in: damage to vessel wall and/or vessel rupture.Rupture of balloon.Do not use a pressure inflation device for balloon inflation.Do not use a power injector for injection of contrast medium through distal lumen.Rupture may occur.The coda 40 mm balloon catheter should not be used for dilation of vascular prostheses in iliac or other non-aortic vessels.Injury to vessel wall and/or rupture may occur.The coda 40 mm balloon catheter should not be used in vessels less the 24 mm diameter.Potential adverse events vessel dissection, perforation, rupture, or injury balloon inflation volume do not exceed maximum inflation volume.Adhere to balloon inflation parameters as shown in fig.1.Over-inflation of balloon may result in: damage to vessel wall and/or vessel rupture.Rupture of balloon.Maximum inflation volumes: catheter size, max.Volume.Coda-2-10.0-35-120-40 40 cc, coda-2-9.0-35-100-32 30 cc, coda-2-9.0-35-120-32 30 cc, balloon introduction and inflation.Caution: prior to introduction, determine the amount of standard 3:1 saline and contrast mixture needed to inflate the balloon to the desired inflation diameter.Refer to the balloon inflation parameters chart in fig.1.Over-inflation of the balloon may result in damage to vessel wall and/or vessel rupture.If balloon pressure is lost and/or balloon rupture occurs, deflate the balloon, and remove balloon and sheath as a unit.Note: care should be taken to monitor balloon manipulations and inflation using fluoroscopy at all times.Based on the information provided, inspection of the returned devices, and the results of the investigation, a definitive root cause for the rupture of the first balloon used nor the inability to occlude the aorta using the second balloon could be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: CODA LP BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15142073
• MDR Text Key: 297034643
• Report Number: 1820334-2022-01300
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002038315
• UDI-Public: (01)10827002038315(17)250601(10)14762377
• Combination Product (y/n): N
• PMA/PMN Number: K150970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Device Lot Number: 14762377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 75 KG