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	11/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported access was gained from left radial artery to the lesion of right external iliac artery (eia).Reportedly the patient did not have a tortuous anatomy or calcification of common iliac artery (cia).The patient's anatomical form was reported to be suitable for the procedure.The device was advanced into the occluded stent over the placed wire guide (another manufactures' wire guide, 0.014inch), and inflated, however, it ruptured before it reached nominal pressure.Another device was used instead to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
A review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), trends, quality control, functional testing, and visual inspection of the returned device and photographs was conducted during the investigation.Photographic images that have been provided confirm the circumferential rupture.One advance 14 lp low profile balloon catheter was returned.No damage was readily apparent to the device.Functional testing was performed to verify the failure.The device was leak-tested by inflating the balloon with a syringe of water.A pin hole was noted approximately 1 cm from the distal end of the balloon.No other damage was observed.The reported rupture could not be confirmed upon physical inspection of the returned device.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Instructions for use are included with the device that advise on proper handling and use to prevent damage.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: 6185808
• Report Number: 1820334-2016-01529
• Device Sequence Number: 89548
• Product Code: DQY
• UDI-Device Identifier: 10827002503356
• UDI-Public: (01)10827002503356(17)180918(10)6217517
• 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): 04/07/2017

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: PTAX4-14-170-4-4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1