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

Model Number	2200-3510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's dob or age at time of event, and weight are unknown.This information was not available from the facility.During advancement, the angiosculpt device separated in two pieces.Although the separated portion occurred outside of the body, this is being reported conservatively.Recurrence of this malfunction could result in a prolonged procedure.Patient information regarding relevant tests/ laboratory data or medical history are unknown.This information was not available from the facility.The angiosculpt device was returned in two pieces.Visual examination found the proximal shaft separated approximately 25.5 inches from the distal tip.No shaft buckling was noted, however 3 kinks were observed on the shaft.Based on the complaint details, manipulation of the catheter by the user caused or contributed to the shaft separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
During insertion of the angiosculpt device into the guide catheter, resistance was felt and the proximal shaft buckled and kinked.As the physician straightened out the kink, the shaft broke in his hands.The distal portion of the device was still in the guide catheter; however, the separated portion occurred outside of the patient's body.A new device was used to complete the procedure.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: 9863084
• Report Number: 3005462046-2020-00003
• Device Sequence Number: 3432612
• Product Code: NWX
• UDI-Device Identifier: 00813132021238
• UDI-Public: 00813132021238
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2022
• Device Model Number: 2200-3510
• Device Catalogue Number: 2200-3510
• Device Lot Number: G19100006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• 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: 02/27/2020
• Initial Report FDA Received Date: 03/20/2020
• 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: Other
• Date Report Sent to FDA: 01/01/2005