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

Model Number	2076-4040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inflation, the balloon ruptured below rbp.No patient injury, this mdr is being reported conservatively.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.An undersized introducer sheath (5f) was used.The product label indicates the angiosculpt device is compatible with a 6f introducer sheath.Report source: foreign- (b)(6) the angiosculpt device was infectious and discarded by the facility, thus no returned product investigation was performed.(b)(4).
Event or Problem Description
The angiosculpt device was used and during the first inflation at 8 atm for 5 seconds, the balloon ruptured.The procedure was completed with a new angiosculpt device.No patient injury reported.
Additional Manufacturer Narrative
Block h6: added codes 419 (balloon) and 2199 (no health consequences or impact).

• 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: 11773819
• Report Number: 3005462046-2021-00023
• Device Sequence Number: 3438564
• Product Code: PNO
• UDI-Device Identifier: 00813132021351
• UDI-Public: 00813132021351
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K100303
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 05/23/2022
• Device Model Number: 2076-4040
• Device Catalogue Number: 2076-4040
• Device Lot Number: G19050032
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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: 0.018" KYOUSHA GUIDE WIRE; MEDIKIT: 5F ULTRA HIGH FLOW SHEATH/GUIDE