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

Model Number	2076-5040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
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 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.Foreign: (b)(6).The angiosculpt device was returned blood-stained.Visual inspection found no unusual characteristics of the device.During functional testing, the balloon was pressurized and at less than 2 atm, a pinhole leak was observed in the middle of the balloon.The ifu warns at least 99.9% of the balloons (with a 95% confidence level) will not burst at or below the rbp.In addition, the health effect impact code (heic) field was intentionally left blank.A supplemental mdr to follow upon availability to enter code: (b)(4) (no health consequences or impact).
Event or Problem Description
During the 1st inflation at nominal pressure (8 atm) for 20 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: 11701178
• Report Number: 3005462046-2021-00021
• Device Sequence Number: 14430602
• Product Code: PNO
• UDI-Device Identifier: 00813132021375
• UDI-Public: 00813132021375
• 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): 03/31/2021

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: 11/08/2022
• Device Model Number: 2076-5040
• Device Catalogue Number: 2076-5040
• Device Lot Number: G19110011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH