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

Model Number 2200-3510

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 10/09/2020

Event Type  Injury  

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 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.

Manufacturer Narrative

Block d11: guide catheter size was updated from unk to 6f.

• 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
• MDR Report Key: 10801170
• MDR Text Key: 215045826
• Report Number: 3005462046-2020-00048
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021238
• UDI-Public: 00813132021238
• Combination Product (y/n): Y
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Hospitalization; Required Intervention