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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported device has been received, an evaluation is in progress.
Event or Problem Description
It was reported that during a fistulagram procedure, the advance 35 lp low profile balloon catheter ruptured at 6 atm.The fistula was in the forearm and there was angulation.The reporter stated there was no calcification but a stent was in place.The cook representative stated that the burst appeared to be from a pinhole.The contrast being used as 50% visipaque and 50% heparinized saline.There was no unintended section of the device left inside of the patient's body.There was no additional procedures done.The patient was unharmed.No additional details have been received.
Additional Manufacturer Narrative
A review of the dimensional verification, complaint history, device history record, instructions for use (ifu), quality control and a visual inspection of the returned device was conducted for the purpose of this investigation.One advance 35 lp low profile balloon catheter was returned for investigation.A leak test was performed and a pinhole leak was observed in the balloon.The leak was noted 1 cm from the distal end.A complaint history search noted this is the only complaint related under its lot.There is no evidence to suggest the product was not manufactured to current specifications.The ifu included with the device instructs the following: "do not exceed rated burst pressure.Rupture of balloon may occur.Over-inflation may cause rupture of the balloon, with result damage to the vessel wall.The burst pressure data was analyzed using factors for a one-sided tolerance to determine with 95%confidence that 99.9% of these balloons would not burst at or below the calculated rated burst pressure.In heavily scarred access sites, 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 catheter to ensure no damage has occurred." it is likely that the patient's anatomy may have contributed to the device failure; however based on the available information a definitive root cause could not be determined.We will continue to monitor for similar events.

• 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: 6422181
• Report Number: 1820334-2017-00448
• Device Sequence Number: 1102245
• Product Code: DQY
• UDI-Device Identifier: 10827002523521
• UDI-Public: (01)10827002523521(17)200104(10)7562956
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2017

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: N/A
• Device Catalogue Number: PTA5-35-80-7-4.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1