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 Consequences Or Impact To Patient (2199)
Date of Event	12/16/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field for section could not be populated due to a technical limitation.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 advance enforcer 35 focal force pta balloon catheter burst at 15 atm (atmospheres) during a pta (percutaneous transluminal angioplasty) of a heavily calcified sfa (superficial femoral artery).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: 8168839
• Report Number: 1820334-2018-03795
• Device Sequence Number: 2015989
• Product Code: PNO
• UDI-Device Identifier: 10827002352527
• UDI-Public: (01)10827002352527(17)150902(10)5251463
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• 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: 09/02/2015
• Device Catalogue Number: ASB5-35-80-6-4
• Device Lot Number: 5251463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2015
• 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