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

Model Number	2092-4040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2020
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.Foreign: (b)(6).The angiosculpt device was returned with a stopcock attached to the inflation port.Visual inspection found no unusual characteristics of the device.During functional testing, the device was pressurized at less than 2 atm and a leak was observed.Under microscopic inspection, a longitudinal tear on the balloon was noted.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 a moderately calcified and moderately tortuous lesion.During the second inflation at 12 atm, the balloon ruptured.The procedure was completed with a new angiosculpt 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: 11032936
• Report Number: 3005462046-2020-00054
• Device Sequence Number: 2692239
• Product Code: PNO
• UDI-Device Identifier: 00813132021405
• UDI-Public: 00813132021405
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K100303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2020

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: 04/12/2020
• Device Model Number: 2092-4040
• Device Catalogue Number: 2092-4040
• Device Lot Number: G18040018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2020
• 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