MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW); CATHETER, PERCUTANEOUS, CUTTING/SCORING

Model Number	2237-40100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's weight is unknown.This information was not available from the facility.During inflation, the balloon ruptured below rbp.No patient injury, this mdr is being reported conservatively.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.The angiosculpt device was discarded by the facility, thus no returned product investigation was performed.An oversized guidewire (0.018") was used.The product label indicates the angiosculpt device is compatible with a 0.014" guidewire.
Event or Problem Description
The angiosculpt device was used to treat a moderately calcified mid sfa.During inflation at 8 atm, a pinhole leak was detected since contrast could be seen on the angio.The procedure was completed with a new device.No patient injury reported.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Common Device Name: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 11211150
• Report Number: 3005462046-2021-00003
• Device Sequence Number: 3360465
• Product Code: PNO
• UDI-Device Identifier: 00813132022822
• UDI-Public: 00813132022822
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K142983
• 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
• Report Date (Section B): 12/29/2020

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: 04/06/2022
• Device Model Number: 2237-40100
• Device Catalogue Number: 2237-40100
• Device Lot Number: G20040006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR