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

Model Number	2200-2510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's dob, age at time of event, gender, or weight are unknown.This information was not available from the facility.During withdrawal, the angiosculpt device separated in two pieces.Surgical intervention was required to remove from the patient.No piece of the angiosculpt device was retained in the patient.Foreign - (b)(6).The angiosculpt device was returned with just the proximal portion of the catheter measuring at 111 cm (core wire, proximal bond, proximal shaft, hypotube, hypotube bond, strain relief, and hub).The device separated proximal to the rx port.The core wire was intact and exposed beyond the proximal shaft.Per specification, approximately 26 cm of the distal assembly was not returned (distal tip, distal bond, balloon, marker bands, scoring element, intermediate bond, and transition tubing).Based on the complaint details, the angiosculpt device got stuck on the lesion.It is likely that some degree of force was applied by the user, resulting in the shaft separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
The angiosculpt device was inflated and deflated with no issues in the proximal lad.During withdrawal, resistance was noted and the device was unable to be removed from the lesion.When the physician tried to pull it out, the device snapped in two pieces.As a result, cabg was performed to retrieve the distal portion of the device.No piece of the device was retained in the patient.

• 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: 9528623
• Report Number: 3005462046-2019-00016
• Device Sequence Number: 14246918
• Product Code: NWX
• UDI-Device Identifier: 00813132021177
• UDI-Public: 00813132021177
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• PMA/510(K) Number: P050018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2019
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2022
• Device Model Number: 2200-2510
• Device Catalogue Number: 2200-2510
• Device Lot Number: G19040022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• 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: 12/04/2019
• Initial Report FDA Received Date: 12/29/2019
• 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