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

Model Number 2200-3510

Device Problem Difficult to Remove (1528)

Patient Problem Angina (1710)

Event Date 07/24/2019

Event Type  Injury  

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 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)
• Type of Device: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 8874027
• MDR Text Key: 153677894
• Report Number: 3005462046-2019-00009
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021238
• UDI-Public: 00813132021238
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC: 0.014" MARVEL GUIDEWIRE; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention