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

Model Number N/A

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported the coda balloon of a coda lp balloon catheter ruptured during a procedure.During the procedure, a sheath (16 french) was used to introduce the balloon.The balloon was inflated in the top cover of the graft.In the area of inflation of the cook coda balloon, there was no angulation or calcification present.The cook coda balloon ruptured during the procedure.The location on the catheter where the balloon ruptured is unknown.It was fully deflated and removed over a wire guide.Vacuum on the inflation syringe was not maintained during the removal.A new cook coda balloon was used to complete the procedure.It was also noted that there was no significant tortuosity of the patient's vessels and no calcification was present in the vessels used for introduction of the devices.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.A2 - age: patient born year 1973 e1 - customer (person): street: (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 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 or that a death or serious injury occurred; nor is it admission 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

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 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 or that a death or serious injury occurred; nor is it admission 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

Additional information was provided on 27mar2024.The coda balloon was inflated in the first covered stent of the zimb-36-98.Following the procedure there were no consequences for the patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported that the balloon of a coda lp balloon catheter ruptured during an aorta procedure.The balloon was inflated at the top of the graft.The balloon was fully deflated prior to the attempted removal with the wire guide in place.There was no angulation at the inflation site.The patient did not have any vessel calcification near the inflation site nor in the vessel at the introduction site of the devices.The same sheath was used, but another coda was obtained to complete the procedure successfully.Reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications, as well as a visual inspection of the returned device, were conducted during the investigation.One used complaint device was returned to cook for investigation.Upon physical examination of the returned device, the coda balloon was noted to be ruptured near the distal end of the device.The marker bands are intact, and no other damage was noted.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed two non-conformance in which two devices were scrapped.A complaint history search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.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.Based on the information provided, inspection of the returned device, and the results of the investigation, cook could not determine a definitive cause for the reported failure.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 the patient and/or event 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: 18926242
• MDR Text Key: 337948306
• Report Number: 1820334-2024-00372
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002038315
• UDI-Public: (01)10827002038315(17)261220(10)15813830
• 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,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• 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: 15813830
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2023
• 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
• Treatment: COOK ZSLE-16-74-ZT; COOK ZIMB-36-98; COOK ZSLE-20-56-ZT
• Patient Sex: Male