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	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: k130293.The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported that during an angioplasty procedure involving a (b)(6) male, the advance 18 lp balloon ruptured.It was removed from the patient, and another balloon was not needed as this was the end of the procedure.No unintended section of the device remained inside the patient¿s body.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, 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 18 lp low profile balloon catheter was returned for evaluation.The balloon was inflated and a pinhole was observed at the proximal bond.The pinhole in the balloon was at 15.9cm from the distal end.The pinhole was at the proximal bond of the catheter.The distal bond was smooth and free of cracks, peeling, voids or excessive foreign matter.Kinks were noted 51.5cm and 110.5cm from the proximal hub.The balloon did not burst.A document-based investigation was performed.Review of the device history record of the finished product shows three nonconforming events that could contribute to this failure mode; however, all nonconforming product was scrapped prior to completion of the finished product.There were no other reported complaints for this lot number.The balloon is 100% inspected and verified prior to release.Based on the provided information, inspection of returned product, and the investigation, definitive root cause could not be determined.Measures have been initiated to address this issue.We will notify the appropriate personnel and 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: 6785894
• Report Number: 1820334-2017-02249
• Device Sequence Number: 1115543
• Product Code: LIT
• UDI-Device Identifier: 10827002309446
• UDI-Public: (01)10827002309446(17)200509(10)7898036
• 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
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1