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

Model Number	2200-3510
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's dob or age at time of event, weight, ethnicity, and race are unknown.Attempts to obtain the information has not been successful.During withdrawal, the angiosculpt device separated in two pieces.Additional intervention was performed, resulting in a prolonged procedure.Patient information regarding relevant tests/laboratory data, or medical history is unknown.Attempts to obtain the information has not been successful.The angiosculpt device was not returned and kept at the facility for internal investigations.Although no piece of the angiosculpt device was left in the patient, retained device component is listed in the ifu as a possible adverse effect of the procedure.
Event or Problem Description
The angiosculpt device was delivered to the lesion with no resistance.Using an endoflator, negatived air was applied and blood was observed on the endoflator.During removal, the proximal shaft separated inside the guide catheter; therefore, the device was removed as a unit.Rewiring of the lesion was required to complete the procedure with a new angiosculpt device.No patient injury reported.
Additional Manufacturer Narrative
Block d11: guide catheter size was updated from unk to 6f.

• 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: 10801170
• Report Number: 3005462046-2020-00048
• Device Sequence Number: 19725280
• Product Code: NWX
• UDI-Device Identifier: 00813132021238
• UDI-Public: 00813132021238
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 10/09/2020

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: 11/08/2022
• Device Model Number: 2200-3510
• Device Catalogue Number: 2200-3510
• Device Lot Number: G19110006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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" PILOT GUIDE WIRE; CORDIS: 6F GUIDE CATHETER; CORDIS: GUIDE CATHETER SIZE UNK; TERUMO: 6F SLENDER INTRODUCER SHEATH; ABBOTT: 0.014" PILOT GUIDE WIRE; CORDIS: GUIDE CATHETER SIZE UNK; TERUMO: 6F SLENDER INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention