MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW); CATHETER, PERCUTANEOUS, CUTTING/SCORING

Model Number	2216-20100
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's gender, dob or age at time of event, and weight are unknown.This information was not available from the facility.During advancement, the angiosculpt device got stuck on the guide wire and was unable to be removed, thus was removed as a unit.A new guide wire and device was required to complete the procedure.This resulted in a prolonged procedure.No patient injury reported.Patient information regarding relevant tests/laboratory data or medical history are unknown.The information was not available from the facility.The angiosculpt was returned intact to a 0.014¿ guide wire.Visual examination found the balloon, transition tubing, and inner member inside the balloon was wrinkled.The scoring element was damaged and the shaft and inner member near the proximal end was accordion.In addition the strain relief was damaged.During functional testing, the guide wire was unable to be removed from the device.Per the ifu, if resistance is met during manipulation, determine the cause of the resistance before proceeding.
Event or Problem Description
After two inflation, the angiosculpt got stuck on the guide wire and could not be moved to a different target area.The device and guide wire were removed as a unit with no patient injury.The lesion was rewired and completed with another balloon.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Common Device Name: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 8577847
• Report Number: 3005462046-2019-00005
• Device Sequence Number: 1837092
• Product Code: PNO
• UDI-Device Identifier: 00813132022891
• UDI-Public: 00813132022891
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K142983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: 2216-20100
• Device Catalogue Number: 2216-20100
• Device Lot Number: G18060015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHILIPS: PHOENIX 0.014" GUIDE WIRE; PHILIPS: QUICKCROSS SIZE UNK; TERUMO: 6F GLIDESHEATH SLENDER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Date Report Sent to FDA: 01/01/2005