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

Model Number	G35252
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name = catheter, percutaneous, cutting/scoring; product code = pno.Pma/510(k) number = k141322.(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that during treatment of a popliteal artery stenosis via the femoral artery, the advance enforcer 35 focal force pta balloon catheter longitudinally ruptured during dilatation.It was noted that the patient's popliteal artery was angulated and calcified.Blood was being directly aspirated; the balloon was not being inflated during the event.Another manufacturer's 7 fr sheath, and a wire guide were in place.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.  according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device noted no surface defects of the catheter or balloon.During the functional evaluation of the device, the balloon inflated but would not remain inflated.The balloon itself did not leak, but the distal tip of the catheter did.Crow¿s feet were present on the balloon.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• Brand Name: ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7224429
• Report Number: 1820334-2018-00200
• Device Sequence Number: 11218444
• Product Code: PNO
• UDI-Device Identifier: 10827002352527
• UDI-Public: (01)10827002352527(17)201102(10)8342753
• 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,Followup
• Report Date (Section B): 04/24/2018

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 Model Number: G35252
• Device Catalogue Number: ASB5-35-80-6-4
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1