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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, dimensional verification, documentation, instructions for use (ifu), manufacturing instructions, trends, quality control, and visual inspection of the returned device was conducted during the investigation. One used advance 18 lp low profile pta balloon dilatation catheter was returned for investigation. The balloon is separated at the proximal bond site. Both marker bands are present. The distal separated portion of the balloon is snared with a returned unknown 4 french snare device. An unknown wire guide is a also present. The total length and the balloon length are within specification. The complainant device lot number is unknown. Thus, a review of the device history record, nonconformance history, and related product complaints query could not be conducted. Per the customer, the vascular was tortuous, and ¿a counter clockwise rotation was not known to be used during withdrawal. ¿ the ifu states, ¿choose a balloon appropriate to lesion length and vessel diameter. ¿ and, "upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site. ¿ based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined. Per the quality engineering risk assessment, no further action is required. Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

Manufacturer Narrative

Additional information: pma/510(k) #k130293. (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

Event Description

An advance 18 lp low profile pta balloon dilatation catheter was used in a percutaneous transluminal angio procedure. It was reported that, the target site was accessed via the arm, as the groin could not be accessed. It was reported there was tortuosity of the artirical system and calcification of tb trunk. Upon pulling the balloon back after the procedure was complete, the wire was looped (this was not noticed as a run was not performed) and the balloon sheered off and had to be retrieved with a snare. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6978188
• MDR Text Key: 278007775
• Report Number: 1820334-2017-03639
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: PTAX4-18-170-4-2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/25/2017 Patient Sequence Number: 1