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

Model Number	2200-3515
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Visual inspection found a semi-radial balloon tear and a kinked intermediate shaft.The ifu warns at least 99.9% of the balloons (with a 95% confidence level) will not burst at or below the rbp.
Event or Problem Description
The angiosculpt device was used to treat the proximal lad.During inflation at 10 atm, the balloon ruptured.The balloon was removed over the wire in one piece and the procedure was completed with a new angiosculpt device.No patient injury reported.This product problem is being submitted because a semi-radial balloon tear was confirmed during the returned product analysis.There is a potential for harm if the malfunction were to occur.

• Brand Name: ANGIOSCULPT RX PTCA
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 12694326
• Report Number: 3005462046-2021-00059
• Device Sequence Number: 4126673
• Product Code: NWX
• UDI-Device Identifier: 00813132021245
• UDI-Public: 00813132021245
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P050018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/04/2021

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 Expiration Date: 04/28/2024
• Device Model Number: 2200-3515
• Device Catalogue Number: 2200-3515
• Device Lot Number: G21040082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/25/2021
• 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: 7F LBU GUIDE CATHETER; TERUMO: 0.014" RUNTHROUGH GUIDEWIRE; TERUMO: 6F GLIDESHEATH SLENDER
• Patient Age: 77 YR
• Patient Weight: 89