MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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	03/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Code 510(k) #; k130293.This event is still under investigation.
Event or Problem Description
It was reported that during a superficial femoral artery (sfa) intervention/dilation, while using an advance 18 low profile balloon catheter, the balloon ruptured (circumferentially) while being inflated.It was reported that although there was no angulation, there was heavy calcification of the vessel.At the time the balloon was being withdrawn, there was very little resistance and it was noted to be in 2 pieces.The patient underwent an additional angioplasty procedure using a cook 6x100 balloon.
Additional Manufacturer Narrative
Exact age unknown, patient was reportedly in his (b)(6).Investigation - evaluation a review of the complaint history, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.One used advance 18 lp low profile balloon catheter was returned for investigation.The distal portion of the balloon is missing.The balloon is ruptured radially and the distal marker band is missing.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the available information and the results of the investigation, a definitive root cause to the reported event could not be conclusively determined.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.

• Brand Name: ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6446203
• Report Number: 1820334-2017-00603
• Device Sequence Number: 19040112
• Product Code: LIT
• UDI-Device Identifier: 10827002309644
• UDI-Public: (01)10827002309644(17)191122(10)7464875
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2017

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: PTA4-18-150-6-20
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1