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

Model Number	2249-60200
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	07/08/2020
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 removal, the angiosculpt device got stuck in the sheath and removed as a unit.A new sheath 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 device was returned intact to a 6f introducer sheath.Complaint details state the device could not cross the lesion, however visual examination found the balloon appears to have been inflated.In addition, the scoring element was slightly elevated from the balloon.The introducer sheath was damaged at the distal end, likely caused by the device during the attempt to remove from the introducer sheath.During functional testing, the device was unable to be removed from the introducer sheath since it was obstructed by the bunching of the scoring element.Therefore, a laboratory 6f introducer sheath was used to aide in the removal of the customer introducer sheath, successfully.Per the ifu, if resistance is met during manipulation, determine the cause of the resistance before proceeding.
Event or Problem Description
The angiosculpt device would not cross in a moderately calcified distal anterior tibial artery.Upon removal, the balloon was unable to come out through the sheath.The guide wire remained in the patient, while the balloon and sheath were removed as a unit.Placement of a new sheath and a new angiosculpt device was required to complete the procedure.

• 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: 10369088
• Report Number: 3005462046-2020-00019
• Device Sequence Number: 19075466
• Product Code: PNO
• UDI-Device Identifier: 00813132021573
• UDI-Public: 00813132021573
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2020
• 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: 11/25/2021
• Device Model Number: 2249-60200
• Device Catalogue Number: 2249-60200
• Device Lot Number: G19110031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• 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: 07/08/2020
• Initial Report FDA Received Date: 08/05/2020
• 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