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

Model Number N/A

Device Problems Material Puncture/Hole (1504); Material Rupture (1546)

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

Event Date 05/13/2022

Event Type  malfunction  

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

It was reported that a coda balloon catheter leaked during the temporary occlusion of the common iliac artery to treat intraoperative bleeding from an old pelvic fracture in a 49 year-old female patient.After opening the package, the nurse flushed the lumen with normal saline.The catheter was then inserted into the common iliac artery and advanced smoothly along the wire guide.After correct device placement was confirmed, the user manually pushed normal saline to the fill the balloon catheter.It was noted by the user that the filling effect of the balloon was "not ideal." the balloon was recovered for secondary expansion and it was found that the issue of insufficient filling of the balloon remained.The balloon was immediately removed.In vitro, a very subtle pinhole-like rupture was discovered in the balloon.This lead to the leakage of normal saline, in which the balloon would not fully inflate.A replacement like device was opened to complete the procedure successfully.The patient did not experience any adverse effects due to this occurrence.Additional information regarding event details has been requested, but is currently unavailable.

Event Description

Additional information received 25aug2022 stating that there was no angulation or vessel calcification at or near the inflation site.No adverse effects have been reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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

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.

Event Description

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

Manufacturer Narrative

Correction: h6 - annex a.Investigation / evaluation: chongqing jiatong med.Dev.Co informed cook on 16aug2022 of an event that occurred on 13may2022 regarding a coda balloon catheter (rpn: coda-2-10.0-35-120-32; lot number: 14584209) leaking during the procedure due to a pin hole in the balloon.A 49-year-old female patient underwent temporary occlusion of the common iliac artery to control intraoperative bleeding for an old pelvic fracture.After opening the package, the nurse flushed the lumen with normal saline and then inserted it into the common iliac artery smoothly along the wire guide.After confirming the correct position, the user manually pushed the normal saline to fill the balloon catheter.During this process, the user found that the filling effect of the balloon was not ideal.Then the balloon was recovered for secondary expansion, and it was found the issue of insufficient filling of the balloon remained.The balloon was immediately removed.In vitro, a very subtle pinhole-like rupture was discovered in the balloon.This led to the leakage of normal saline, in which the balloon would not fully inflate.A replacement like device was opened to complete the procedure successfully.It was reported there was no angulation or vessel calcification at or near the inflation site.The patient did not experience any adverse effects due to this occurrence.Reviews of documentation including the complaint history, drawing, device history record (dhr), quality control procedures, specifications, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One used complaint device was returned to cook for evaluation.Upon visual inspection, a small pin hole was noted near the distal end during inflation of the balloon with water.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 dhr for the reported complaint device lot: 14584209 revealed one non-conformance reported but it was scrapped prior to further processing.A database search identified no other complaints reported for this product lot.Evidence provided by the complaint facility, device history record, 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.Cook also reviewed product labeling.The ifu t_coda2_rev4packaged with the device contains the following in relation to the reported failure mode: "warnings: do not exceed maximum inflation volume.Rupture of balloon may occur.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.Do not use a power injector for injection of contrast medium through distal lumen.Rupture may occur.Balloon inflation volume.Do not exceed maximum inflation volume.Rupture of balloon may occur.Adhere to balloon inflation volume parameters as shown below.Over-inflation of balloon may result in damage to vessel wall and/or vessel rupture.Maximum inflation volumes: catheter size: max.Volume: coda-2-10.0-35-120-140, 40 cc, coda-2-10.0-35-120-32, 34 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.5.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.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, inspection of the returned device, and the results of the investigation, cook has determined a definitive cause could not be established for the failure.Physical examination of the returned device showed a small pin hole near the distal end when inflated with water.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.

• Brand Name: CODA 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 ; 8128294891
• MDR Report Key: 15267058
• MDR Text Key: 305255887
• Report Number: 1820334-2022-01374
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002530246
• UDI-Public: (01)10827002530246(17)250308(10)14584209
• Combination Product (y/n): N
• PMA/PMN Number: K032869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-2-10.0-35-120-32
• Device Lot Number: 14584209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 08/25/2022; 12/02/2022; 12/15/2022
• Supplement Dates FDA Received: 08/30/2022; 12/02/2022; 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Weight: 53 KG