MAUDE Adverse Event Report: COOK INC ADVANCE 35 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	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
An advance 35 lp low profile balloon catheter was used in a lower extremity angiogram.It was reported that the patient had previous stents placed that had restenosed; therefore, a new stent was placed inside a pre-existing stent.When a balloon was advanced for post dilatation of the new stent it ruptured at a nominal pressure of 10atm.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 documentation, complaint history, device history review, instructions for use (ifu), trends, manufacturing instructions, specifications, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A document-based investigation was performed.Review of the device history record shows nonconforming events; however, all nonconformance's were scrapped before the work order was processed as normal.A complaint data base search revealed this complaint to be the only reported complaint associated to the complaint lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined; however, measures have been initiated to address this issue.The appropriate personnel have been notified of this event and we will continue to monitor for similar complaints.

• Brand Name: ADVANCE 35 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: 6849533
• Report Number: 1820334-2017-02906
• Device Sequence Number: 712267
• Product Code: LIT
• UDI-Device Identifier: 10827002355320
• UDI-Public: (01)10827002355320(17)191215(10)7523804
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132020
• 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): 11/30/2017

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: PTA5-35-135-5-20.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1