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

Catalog Number	ASB5-35-80-6-4
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2015
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 a pta (percutaneous transluminal angioplasty) in a very calcified sfa (superficial femoral artery).It was noted that there was "very pointed" plaque in the middle of the sfa.The physician started directly with the advance enforcer 35 focal force pta balloon catheter.The balloon was inflated very slowly "atm by atm." the enforcer balloon burst at 6 atm.The stenosis was not open, so the physician dilated another enforcer balloon of the same size very slowly again.However, the second balloon burst at 16 atm.After the angiogram, stenosis was open, so there were no further actions.Both of the complaint devices were noted to be from the same lot, and the product problems 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: 8169656
• Report Number: 1820334-2018-03804
• Device Sequence Number: 1436706
• Product Code: PNO
• UDI-Device Identifier: 10827002352527
• UDI-Public: (01)10827002352527(17)151024(10)5388440
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: 10/24/2015
• Device Catalogue Number: ASB5-35-80-6-4
• Device Lot Number: 5388440
• Was Device Available for Evaluation?: No
• 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: 81 YR