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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported using an inflation device a low profile balloon catheter popped during inflation.Additional information has been requested but not provided at the time of this report.
Additional Manufacturer Narrative
A review of the following: review of complaint history, review of device history record, review of documentation, review of instructions for use (ifu), review of manufacturing instructions (mi), review of quality control (qc), and review of specifications.The affected product was not returned for investigation.There is no evidence to suggest that the product was not manufactured to current specifications.Without visual, dimensional, and/or functional testing of the product, we are unable to determine if this is a manufacturing issue or if the device had been smashed/damaged in transport.A complaint history search revealed this complaint to be the only reported complaint associated to the complaint lot number.Warnings included in the ifu state: "do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.Over-inflation may cause rupture of the balloon, with result damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.Do not use a power injector for balloon inflation or injection of contrast medium through catheter lumen marked "distal." rupture may occur." based on the available information, we are unable to determine if this complaint was contributed to a procedurally related circumstance, human anatomy or device related.

• 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: 6239664
• Report Number: 1820334-2017-00056
• Device Sequence Number: 10928956
• Product Code: DQY
• UDI-Device Identifier: 10827002522524
• UDI-Public: (01)10827002522524(17)191027(10)7391523
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2017

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: PTA5-35-135-4-4.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 05/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1