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

Model Number	2200-3010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's dob, age at time of event, or weight is unknown.This information was not available from the facility.During withdrawal, 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 is 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 discarded, thus no product investigation was performed.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
The angiosculpt device was used to treat a calcified lesion in the lad with no issue during advancement.As the balloon was being removed from the lesion, resistance was noted and the shaft broke in two pieces.The shaft broke outside of the body approximately 1/3 of the way down from the hub and was able to be removed off of the guide wire.No patient injury occurred.

• 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: 10077325
• Report Number: 3005462046-2020-00008
• Device Sequence Number: 14182034
• Product Code: NWX
• UDI-Device Identifier: 00813132021207
• UDI-Public: 00813132021207
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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): 04/28/2020
• 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 Model Number: 2200-3010
• Device Catalogue Number: 2200-3010
• Was Device Available for Evaluation?: No
• 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: 04/28/2020
• Initial Report FDA Received Date: 05/20/2020
• 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