MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTA5-35-80-8-4.0
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during an arteriovenous (av) fistula angioplasty, the advance 35 lp low profile balloon catheter ruptured circumferentially at 12 atmosphere (atm).Another manufacturer's eight (8) fr sheath, and a wire guide were being utilized through the sheath during the event.The patient's lesion was located in the cephalic arch; calcification was present in the fibrotic vein.The procedure was able to be successfully completed utilizing another balloon catheter.A section of the device did not remain inside the patient¿s body.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, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon was separated into two segments.It ruptured longitudinally as well as radially.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 two other reported complaints for this lot number.The device is shipped with an ifu which states: ¿the balloon is manufactured from an extra-thinwall, high-strength, minimally-complaint material.Particular care should be taken in handling the balloon to prevent damage.Do not exceed rated burst pressure.Rupture of balloon may occur.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.The burst pressure data was analyzed using factors for a one-sided tolerance to determine with a 95% confidence that 99.9% of these balloons would not burst at or below the calculated rated burst pressure.In heavily scarred access site, use of an introducer sheath is recommended.Use only the recommended balloon inflation medium.Choose a balloon appropriate to lesion length and vessel diameter.Upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, the examination of the returned product, and the results of our investigation, the root cause was determined to be product use or handling related.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7095455
• Report Number: 1820334-2017-04352
• Device Sequence Number: 1896154
• Product Code: DQY
• UDI-Device Identifier: 10827002523590
• UDI-Public: (01)10827002523590(17)200818(10)8151841
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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 Catalogue Number: PTA5-35-80-8-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1