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

Model Number	2076-5020
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's age at time of event or dob, gender, and weight are unknown.This information was not available from the facility.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 medical history is unknown.This information was not available from the facility.Foreign: (b)(6).The angiosculpt device was infectious and discarded by the facility, thus no returned product investigation was performed.
Event or Problem Description
The angiosculpt device was used in a moderately calcified sfa.During the first inflation under nominal pressure, the balloon could not be inflated and appeared to be leaking air.The procedure was completed with a new angiosculpt device.No patient injury occurred.

• 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: 10454607
• Report Number: 3005462046-2020-00032
• Device Sequence Number: 11752344
• Product Code: PNO
• UDI-Device Identifier: 00813132021368
• UDI-Public: 00813132021368
• 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): 07/29/2020
• 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: 08/02/2020
• Device Model Number: 2076-5020
• Device Catalogue Number: 2076-5020
• Device Lot Number: G17080002
• Was Device Available for Evaluation?: No
• 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: 07/29/2020
• Initial Report FDA Received Date: 08/26/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005