MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING

Model Number	2200-2510
Medical Device Problem Codes	Entrapment of Device (1212); Retraction Problem (1536); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient'' dob, age at time of event, gender, or weight are unknown.This information was not available from the facility.The angiosculpt device was caught on the guide wire and removed as a system.Rewiring of the lesion was required to complete the procedure, resulting in prolongation of the case.No patient injury reported.Patient information regarding relevant tests/ laboratory data or medical history are unknown.This information was not available from the facility.The lot number was not provided, thus the following information are unknown: expiration date and manufacture date.The angiosculpt device was returned intact to a 0.014" guide wire.Visual examination found a damaged and accordion-like balloon and the scoring element was elevated.In addition, the transition tubing, shaft, and core wire were all damaged.During functional testing, the guide wire was unable to be removed from the angiosculpt device.Per the ifu, if unusual resistance is met during manipulation, carefully remove the entire catheter system.
Event or Problem Description
The angiosculpt device was used to treat a moderately calcified rca with slight vessel tortuosity.During insertion, the scoring element got caught on the guide wire and the scoring element started to unravel within the coronary artery.The device could only be removed as a whole system, thus rewiring of the lesion was required to complete the procedure with other interventional balloons and stent.No patient injury reported.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 9613436
• Report Number: 3005462046-2020-00001
• Device Sequence Number: 547135
• Product Code: NWX
• UDI-Device Identifier: 00813132021177
• UDI-Public: 00813132021177
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P050018
• 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): 12/23/2019
• 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 Model Number: 2200-2510
• Device Catalogue Number: 2200-2510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• 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: 12/23/2019
• Initial Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Date Report Sent to FDA: 01/01/2005