MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number G52347

Device Problem Material Puncture/Hole (1504)

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

Event Date 04/13/2022

Event Type  malfunction  

Event Description

As reported, during an endovascular treatment procedure, a hole was found on an advance 35 lp low profile balloon catheter's balloon.Access was obtained in the right femoral artery, and the complaint device was advanced to a lesion in the left external iliac artery.Upon attempted inflation, the balloon would not inflate.The device was removed from the patient and a pinhole was found on the balloon.Another balloon of a different size was used to complete the procedure.There have been no adverse effects to the patient.

Manufacturer Narrative

Customer name and address: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an endovascular treatment procedure, a hole was found on an advance 35 lp low profile balloon catheter's balloon.Access was obtained in the right femoral artery, and the complaint device was advanced to a lesion in the left external iliac artery.Upon attempted inflation, the balloon would not inflate.The device was removed from the patient and a pinhole was found on the balloon.Another balloon of a different size was used to complete the procedure.There have been no adverse effects to the patient.Upon return and initial evaluation of the device, a hole was noted on the shaft of the catheter, not the balloon material.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), specifications, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The used complaint device was returned for investigation.The balloon would not inflate, and a hole was noted on the catheter shaft, approximately 8.4 centimeters from the strain relief.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu states, ¿flush the catheter lumen labeled ¿distal¿ using heparinized saline solution.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this incident.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 has been received since the last report was submitted.

Manufacturer Narrative

The device has been returned and a preliminary evaluation has been performed; however, the investigation is ongoing.The device evaluation summary will be included in a follow up report upon completion of the investigation.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

Upon return and initial evaluation of the device, a hole was noted on the shaft of the catheter, not the balloon material as previously reported.

• Brand Name: ADVANCE 35 LP LOW PROFILE 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: 14220095
• MDR Text Key: 290529311
• Report Number: 1820334-2022-00658
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002523477
• UDI-Public: (01)10827002523477(17)230610(10)13237085
• Combination Product (y/n): N
• PMA/PMN Number: K091527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2023
• Device Model Number: G52347
• Device Catalogue Number: PTA5-35-80-6-8.0
• Device Lot Number: 13237085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2020
• 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