MAUDE Adverse Event Report: COOK INC ADVANCE 14 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	10/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported when the physician was dilating the target lesion with the balloon, the balloon ruptured at the recommended pressure of 8atm.The device was replaced with another balloon catheter and the procedure was completed successfully.No additional information was available at the time of this report.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, manufacturing instructions, specifications, and quality control was conducted during the investigation.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not manufactured according to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should also be noted that there were no other reported complaints for this lot number.The device implicated in this report was not returned to assist with the investigation therefore, no physical examinations could be performed.The hospital reported that the device would not be returned as it was disposed of at the hospital due to hepatitis b virus (hbv.The information regarding direction of the rupture is no longer available due to the device being disposed of.There is no evidence to suggest that the device was not manufactured to specifications.The results of this investigation are inconclusive.We will continue to monitor for similar events.Per the quality engineering risk assessment no further action is required.Cook will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: ADVANCE 14 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: 6106625
• Report Number: 1820334-2016-01326
• Device Sequence Number: 10966591
• Product Code: DQY
• UDI-Device Identifier: 10827002503271
• UDI-Public: (01)10827002503271(17)171218(10)5528034
• Combination Product (Y/N): N
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017

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: PTAX4-14-170-3-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2016
• Supplement Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1