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	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k#: k130293.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
An advance 18 lp low profile balloon catheter was used in a lower extremity angiogram.It was reported, during the second inflation at nominal pressure, the balloon ruptured inside a previously placed zilver flex stent.Prior to balloon inflation, laser atherectomy of in-stent restenosis was performed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, 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.No damage was noted to the catheter or the hub/strain relief.The re-wrap tool was present on the catheter shaft.Leakage was noted at the proximal end.The balloon was ruptured longitudinally and is1.4cm in length.Crows feet was not detected, however this was difficult to note due to bio-material that was present.Both the catheter and balloon length were within specifications.A document-based investigation was performed.The device history record was reviewed and 3 non-conformances were noted; however, they were all scraped before the work order was processed as normal.There were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Measures have been initiated to address this failure mode.The appropriate personnel have been notified and monitoring will continue to be performed 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: 6860089
• Report Number: 1820334-2017-02913
• Device Sequence Number: 1460551
• Product Code: LIT
• UDI-Device Identifier: 10827002309583
• UDI-Public: (01)10827002309583(17)200519(10)7926933
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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: PTA4-18-150-5-20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1