MAUDE Adverse Event Report: SPECTRANETICS CORP. ANGIOSCULPT PTA SCORING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 2034-3015

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Information (3190)

Event Date 11/17/2013

Event Type  malfunction  

Event Description

"i'm not sure what exactly caused the failure.I have used the angiosculpt many times and never had a problem.I used it with a conductor extra support wire from concert medical.I use the medium support version a lot and it's an extremely good wire but this was the first time i used the extra support.The only other circumstance was that the vessel had previous stents.I'm going to have the company look over the balloon but i think it may be premature to report it to medwatch since i can't be sure the device was faulty.One day later: there was no problem with advancing the balloon to the lesion and i had no issue inflating and deflating.What happened was that as i was pulling it back, it wouldn't come back any further when it got to the bend of the proximal rca.It didn't seem stuck on anything but i just couldn't withdraw.I finally just pulled hard (gently?) and it finally came out but pulled the wire out and the guide catheter got sucked in.When we looked at it the wire and balloon seemed to be bound together.We were able to get the guide wire information.However, the barcode of the balloon catheter was discarded so we are unable to retrieve that information.I'm providing the information from a catheter on the shelf that might have been in the same order as the catheter we used.We are taking steps to keep archive information on the devices in the future.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): SPECTRANETICS CORP.; 5055 brandin court; fremont CA 94538
• MDR Report Key: 5494508
• MDR Text Key: 40150862
• Report Number: 5494508
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2014,03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/01/2015
• Device Catalogue Number: 2034-3015
• Device Lot Number: F12070056
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1