MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION ANGIOSCULPT OTW PTA; CATHETER, PTA, 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	08/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: foreign- (b)(6).Visual inspection found a tear on the balloon and a wrinkled transition tubing.During functional testing using an indeflator filled with green color dye water, the device was pressurized and at less than 2 atm, a leak on the balloon was present.Under microscopic inspection, a semi-radial balloon tear was observed.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 severely calcified mid sfa.During inflation, the balloon ruptured at 13 bar.The procedure was completed with a new angiosculpt device.No patient injury reported.This product problem is being submitted because the balloon burst semi-radially below rbp.There is a potential for harm if the malfunction were to occur.

• Brand Name: ANGIOSCULPT OTW PTA
• Common Device Name: CATHETER, PTA, CUTTING/SCORING
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• MDR Report Key: 12434730
• Report Number: 3005462046-2021-00054
• Device Sequence Number: 17039206
• Product Code: PNO
• UDI-Device Identifier: 00813132021375
• UDI-Public: 00813132021375
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• PMA/510(K) Number: K100303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2021

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: 11/06/2023
• Device Model Number: 2076-5040
• Device Catalogue Number: 2076-5040
• Device Lot Number: G20110014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 73