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

Model Number	2155-3040
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	02/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's age at time of event or dob 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 system.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 test/laboratory data or medical history is unknown.This information was not available from the facility.The angiosculpt device was returned partially intact to a 0.014" guide wire.Visual inspection found a damaged distal tip and a tear on the balloon.The entire length of the balloon was wrinkled and the inner member underneath the balloon was severely damaged and accordion.The proximal bond and scoring element was damaged with all struts lifted.The transition tubing was kinked and accordion.The distal shaft, proximal to the proximal bond was necked, stretched, and accordion.During functional testing, the guide wire was unable to be removed from the device.A laboratory guide wire was inserted through the luer and was able to advance to the stuck guide wire.Per the ifu, if resistance is met during manipulation, determine the cause of the resistance before proceeding.
Event or Problem Description
The angiosculpt device got stuck on the guide wire in transit to the lesion; therefore, it was removed as a system.The physician rewired the lesion and completed the procedure with a new angiosculpt device.

• 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: 8377930
• Report Number: 3005462046-2019-00002
• Device Sequence Number: 2887678
• Product Code: PNO
• UDI-Device Identifier: 00813132021320
• UDI-Public: 00813132021320
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2019
• 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: 07/02/2021
• Device Model Number: 2155-3040
• Device Catalogue Number: G18060040
• Device Lot Number: G18060040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• 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: 02/11/2019
• Initial Report FDA Received Date: 02/28/2019
• 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: ABBOTT: 0.014" IRONMAN GUIDE WIRE; TERUMO: 6F DESTINATION SHEATH
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Date Report Sent to FDA: 01/01/2005