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

Model Number	2216-25100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's dob or age at time of event, gender, weight, ethnicity, and race are unknown.This information was not available from the facility.During inflation, the balloon ruptured at 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.Device evaluation anticipated, but not yet begun.
Event or Problem Description
The angiosculpt device was used to treat a severely calcified mid at.During inflation at 16 atm for 2 minutes, the balloon deflated and ruptured.A new angiosculpt device was used to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Block d9: corrected date from initial mdr from 06/01/2021 to 06/08/2021.Block g3: the angiosculpt device was returned for evaluation.Block h3: visual examination found a distal bond peel, but remained intact to the device and an elevated scoring element observed.During functional testing, the device was pressurized and at less than 2 atm, a leak on the balloon was present.Under microscopic inspection, a longitudinal tear was noted.Block h6: per the ifu, at least 99.9% of the balloons (with a 95% confidence level) will not burst at or below their rbp.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Common Device Name: CATHETER, PTA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 11971442
• Report Number: 3005462046-2021-00033
• Device Sequence Number: 11051152
• Product Code: PNO
• UDI-Device Identifier: 00813132022907
• UDI-Public: 00813132022907
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K142983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: 03/04/2023
• Device Model Number: 2216-25100
• Device Catalogue Number: 2216-25100
• Device Lot Number: G21030009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 06/23/2021
• 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: ABBOTT: 0.014" COMMAND GUIDE WIRE; COOK: 6F INTRODUCER SHEATH