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

Model Number	2200-3510
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Angina (1710)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's dob, age at time of event, or weight is unknown.During withdrawal the angiosculpt device got stuck on sharp calcium chuck.Additional intervention was required to remove from the patient, thus resulted in a prolonged procedure.In addition, lab analysis confirmed a shaft separation.Patient information regarding relevant tests/laboratory data, or medical history is unknown.The angiosculpt device was returned in two pieces.The device separated at the intermediate shaft proximal to the rx port.The intermediate shaft was flattened from the rx port.The hypotube was kinked and the core wire was bent at the distal end and proximal end.Based on the lab analysis, it is probable the user applied excessive exertion of force to try and remove from the calcium, which resulted in the shaft separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
Patient had previously placed stents in left main and lad with significant in-stent restenosis.The vessel was highly calcified, with moderate tortuosity.The physician decided to treat with a 3.5 mm x 10 mm angiosculpt device.After inflating it twice, the balloon could not be removed and believed it got stuck on a sharp calcium chunk.The physician was able to get a guideliner to abut the angiosculpt scoring element and get a 3.5 mm x 30 mm non-compliant balloon distal to the angiosculpt balloon on a buddy wire to pull the balloon back into the guideliner.The patient experienced mild angina during removal, but otherwise was discharged the following day with good flow and no complications.

• 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: 8874027
• Report Number: 3005462046-2019-00009
• Device Sequence Number: 2070676
• Product Code: NWX
• UDI-Device Identifier: 00813132021238
• UDI-Public: 00813132021238
• Combination Product (Y/N): Y
• Initial Reporter State: HI
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2019
• 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: 03/18/2022
• Device Model Number: 2200-3510
• Device Catalogue Number: 2200-3510
• Device Lot Number: G19030021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• 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: 07/25/2019
• Initial Report FDA Received Date: 08/08/2019
• 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: BOSTON SCIENTIFIC: 0.014" MARVEL GUIDEWIRE; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Date Report Sent to FDA: 01/01/2005