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

Model Number	G35250
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name: catheter, percutaneous, cutting/scoring; product code: pno.Pma/510(k) number = k141322.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that while testing the advance enforcer 35 focal force pta balloon catheter with a syringe to observe the pattern of burst, the end of the balloon detached from the catheter.It was noted that the balloon inflated in a "non traditional" manner.The balloon catheter did not come into contact with a patient.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One device was returned with biomatter present.The balloon was separated from the distal joint.The balloon was still connected at the proximal end.The catheter outer diameter measured within specification.The length of the distal tip could not be obtained because the tip was likely distorted during separation of the balloon material from the catheter.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirement, each balloon is 100% inspected and verified prior to release.Review of the device history record shows non-conforming events; however, all non-conforming product was scrapped or reworked prior to completion of the final lot.In addition, there were no other complaints reported for this lot number.Based on the information provided, examination of the returned device, and the results of our investigation; the root cause has been determined to be related to user technique, as the facility reported the balloon was inflated non-traditionally.Per the risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7046589
• Report Number: 1820334-2017-04007
• Device Sequence Number: 10991170
• Product Code: PNO
• UDI-Device Identifier: 10827002352503
• UDI-Public: (01)10827002352503(17)200120(10)7608840
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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: G35250
• Device Catalogue Number: ASB5-35-50-10-4
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1