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	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that during an iliac percutaneous transluminal angioplasty using an advance 35 low profile balloon catheter, upon inflation, the balloon ruptured at 3atm.At the time of this report, it is unknown which direction the balloon burst.The type of contrast that was used was unknown.The mixture of contrast to saline was said to be 50/50.The lesion was located in the right common iliac.The vessel was described to have a small amount of angulation and calcification.No part of the device remained in the patient's body.The patient did not require additional procedures as a result of this event.
Additional Manufacturer Narrative
A review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The device history record was reviewed.During the manufacturing process, the quantity of the work order was shorted during the ¿balloon folding¿ process.Therefore, the non-conformance is related to this complaint.There were no other reported complaints for this lot number.One used advance 35 lp low profile balloon catheter was returned for evaluation.The balloon had a horseshoe-shaped hole which was noted at 3.6cm from the distal tip.The hole measured 1mm in diameter.The balloon did not burst radially.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• 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: 6522630
• Report Number: 1820334-2017-00694
• Device Sequence Number: 18834964
• Product Code: DQY
• UDI-Device Identifier: 10827002522661
• UDI-Public: (01)10827002522661(17)181209(10)6439669
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2017

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: PTA5-35-135-6-6.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1