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

Model Number	2249-50200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Atherosclerosis (1728); Peripheral Vascular Disease (2002)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During removal, the angiosculpt device separated in the patient.Additional intervention was required to remove from the patient, thus resulted in a prolonged procedure.No piece of the angiosculpt device was retained in the patient.Patient information regarding relevant tests or laboratory data is unknown.This information was not available from the facility.The angiosculpt device was returned without the distal tip, distal bond, balloon, and scoring element.The device separated at the intermediate bond.The transition tubing and shaft was severely stretched.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
The angiosculpt balloon was inserted over a.014" e s"port guide wire and resistance was noted tracking to the lesion.The balloon was inflated to 6 atm for 3 min.The balloon was deflated and attempted to remove from the body.During removal it was discovered that a kink in the wire had appeared and became difficult to remove.When the scoring element of the balloon engaged the 6f sheath, it became more difficult to pull out.While attempting to remove, the distal shaft broke.The balloon and scoring element became trapped in the distal portion of the sheath.The patient was sent to surgery to remove the remaining device from the patient's leg.

• 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: 7677490
• Report Number: 3005462046-2018-00015
• Device Sequence Number: 848456
• Product Code: PNO
• UDI-Device Identifier: 00813132021566
• UDI-Public: 00813132021566
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K133998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2018
• 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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/22/2019
• Device Model Number: 2249-50200
• Device Catalogue Number: 2249-50200
• Device Lot Number: G17110032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• 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: 06/22/2018
• Initial Report FDA Received Date: 07/11/2018
• 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 EXTRA S''PORT GUIDE WIRE; TERUMO: 6F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 85
• Date Report Sent to FDA: 01/01/2005