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 Consequences Or Impact To Patient (2199)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k130293.(b)(4).Device has been received, evaluation pending.
Event or Problem Description
It was reported that the balloon burst at 4 atmospheric pressure.The patient remained unharmed.No additional information at this time.
Additional Manufacturer Narrative
Evaluation - one used advance 18 low profile balloon catheter returned for investigation.The balloon was ruptured and covered with what appeared to be bio-material.Printing and strain relief are correct, clean and legible; additionally the strain relief is clean and secure.The y-fitting is clean and free of damages.The length of balloon catheter is within specification.No defects were noted.The marker bands are present.Physical and function testing were performed, but were difficult due to possible bio-matter material on the balloon catheter.The catheter balloon was not able to be inflated and the marker bands could not be measured in direct relationship to the balloon, but were noted for being present.Due to the condition of the returned device, we are unable to determine with certainty what led to the confirmed failure.Therefore, a conclusive root cause cannot be determined.A review of the complaint history, device history record, ifu, quality control and visual inspection of the returned device was conducted.No events related to the reported issue were found during a review of related manufacturing or quality records.Review of the associated device history record did not identify non-conformances that may be related to this reported incident.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a changed is not required, thus no risk reduction activities are required at this time.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Event or Problem Description
Additional information received on 01/23/2017 stated that a 7 french sheath was utilized.The wire guide was in place during inflation and removal.The lesion was located in the anterior tibial artery.There was no angulation or calcification of the vessel.There is no information provided that states whether or not the advance 18 lp low profile balloon catheter was allowed to return to ambient pressure once the device was deflated.

• 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: 6248965
• Report Number: 1820334-2017-00097
• Device Sequence Number: 938514
• Product Code: LIT
• UDI-Device Identifier: 10827002309446
• UDI-Public: (01)10827002309446(17)190414(10)6891202
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2017

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: PTA4-18-150-3-15
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1