MAUDE Adverse Event Report: COOK INC ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

Catalog Number	ASB5-35-135-12-4
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name: pno catheter, percutaneous, cutting/scoring.Product code: pno.This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The complainant reported that the doctor had used another manufacturer's device and performed thrombolysis.There was persistent intrastent thrombus, so the doctor needed to balloon through that.The balloon on the advance enforcer 35 focal force pta balloon catheter ruptured while ballooning a series of stents.It did "well" at ballooning the top and middle stents, but ruptured on the inferior aspect of the wall stent.The enforcer burst longitudinally at a rate of approximately 6atm (atmospheres).Another manufacturer's balloon was used to balloon the distal stent, and it did not rupture.This product problem did not result in any reported serious injuries to the patient.

• Brand Name: ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8169684
• Report Number: 1820334-2018-03801
• Device Sequence Number: 2016061
• Product Code: PNO
• UDI-Device Identifier: 10827002352619
• UDI-Public: (01)10827002352619(17)150910(10)5271219
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2015
• Device Catalogue Number: ASB5-35-135-12-4
• Device Lot Number: 5271219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR