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

Model Number	2076-6040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's dob or age at time of event, weight, ethnicity, and race are unknown.Attempts to obtain the information has not been successful.During inflation, the balloon ruptured below rbp.Recurrence of this malfunction could result in a flow limiting dissection or perforation.No patient injury reported.This mdr is being reported conservatively.Patient information regarding relevant tests/laboratory data or medical history are unknown.Attempts to obtain the information has not been successful.Visual inspection found no unusual characteristics of the device.During functional testing, using an indeflator filled with warm water, the balloon was pressurized at less than 2 atm and a leak was observed.Under microscopic inspection, a longitudinal tear was noted along the proximal portion 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.
Event or Problem Description
The angiosculpt device was used in a severely calcified and moderately tortuous mid sfa.During 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: 10486030
• Report Number: 3005462046-2020-00034
• Device Sequence Number: 4060258
• Product Code: PNO
• UDI-Device Identifier: 00813132021399
• UDI-Public: 00813132021399
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2020
• Report Date (Section F): 01/01/2005

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: 01/23/2022
• Device Model Number: 2076-6040
• Device Catalogue Number: 2076-6040
• Device Lot Number: G19010028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 09/02/2020
• 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
• Date Report Sent to FDA: 01/01/2005