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

Model Number G52352

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, during an angioplasty of the sfa a advance 35 lp low profile balloon catheter was in use, but as it was being inflated it burst.The user then removed the balloon over the wire and through the sheath without issue.No portion of the device remained inside the patient.This event did not result in additional procedures or prolonged hospitalization.No adverse effects to the patient occurred.Additional information was requested and a follow-up report will be submitted if/when it is received.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an angioplasty of the sfa an advance 35 lp low profile balloon catheter was in use, but as it was being inflated it burst.The user then removed the balloon over the wire and through the sheath without issue.No portion of the device remained inside the patient.This event did not result in additional procedures or prolonged hospitalization.No adverse effects to the patient occurred.Investigation evaluation: reviews of the complaint history, device history record, drawing, documentation, instructions for use (ifu), manufacturing instructions, quality control, and specifications were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation with biomatter present.Physical examination of the returned device showed that there was no visible damage to the shaft, and the balloon was not visibly damaged.An attempt was made to inflate the balloon; however, the balloon would not inflate.The device was decontaminated for 5 days.A second attempt was made to flush and inflate the balloon after decontamination; however, that attempt was also unsuccessful.It is suspected that there is potential biomatter within the balloon lumen causing the balloon to be unable to be inflated.Although it is possible that there is a pinhole in the balloon, this is unable to be confirmed, as the balloon cannot be inflated.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 information provided upon review of complaint file, device history record, complaint history, device master record, and design verification testing provide objective evidence to support that the device was manufactured to specification.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, it was concluded that there is no evidence that nonconforming product exists in-house or in the field.A device master record review was performed, including device specifications, drawings, manufacturing instructions, and quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The label on the product package and the compliance card insert indicate that for the pta5-35-80-7-4.0, the nominal inflation pressure is 8atm and the rated burst pressure is 12atm.The ifu also instructs the user to adhere to the balloon inflation pressure parameters indicated on the labeling.The ifu warns not to exceed the rated burst pressure, as rupture may occur.Based on the information provided and the results of the investigation, cook has concluded that a definitive cause for the event could not be determined.The risk analysis for this failure mode was reviewed and no action 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 regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• MDR Report Key: 10378972
• MDR Text Key: 202022935
• Report Number: 1820334-2020-01448
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002523521
• UDI-Public: (01)10827002523521(17)221001(10)10052716
• Combination Product (y/n): N
• PMA/PMN Number: K091527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: G52352
• Device Catalogue Number: PTA5-35-80-7-4.0
• Device Lot Number: 10052716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1