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	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested but not yet received.The event is currently under investigation.
Event or Problem Description
It was reported during a lower leg angiogram, using an advance 14 low profile balloon catheter, the balloon ruptured during the procedure.The direction in which the balloon ruptured is unknown.No part of the balloon detached from the device.The targeted lesion was the anterior tibial artery.The vessel was said to have no angulation and only mild calcification.The inflation pressure used at the time of rupture was 6 atm.Contrast mixture was 3 ml of contrast and 5ml of saline.The patient did not require any additional procedures due to this occurrence.
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.One advance lp low profile balloon catheter was returned for investigation.Inspection of the device noted a pin hole located at the apex of the proximal end of the balloon.Bonds were smooth and free of damage and defects.The balloon measured within specifications and the working length measured within specifications.The balloon did not burst; it had a pin hole leak.There is no evidence to suggest the product was not manufactured to current specifications.Review of the device history record shows no nonconformance of released product.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 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: 6482328
• Report Number: 1820334-2017-00671
• Device Sequence Number: 19154691
• Product Code: DQY
• UDI-Device Identifier: 10827002503332
• UDI-Public: (01)10827002503332(17)191212(10)7511567
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090822
• 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): 04/11/2017

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: PTAX4-14-170-3-20
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 05/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1