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

Model Number	2092-4040
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
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.The angiosculpt device ruptured when inflated to 16 atm, which is above rbp (14 atm).Recurrence of the malfunction could result in a vessel dissection requiring possible stent.Report source: foreign- (b)(6).The angiosculpt device was not returned, thus no product investigation was performed.The angiosculpt device was used off-label.The ifu warns to not exceed the rated burst pressure as indicated on the product label.
Event or Problem Description
During the third inflation at 16 atm for 30 seconds, the balloon ruptured.A cutting balloon catheter was alternatively used to complete the procedure.

• 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: 8115033
• Report Number: 3005462046-2018-00024
• Device Sequence Number: 19422526
• 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): 11/01/2018
• 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: 04/12/2021
• Device Model Number: 2092-4040
• Device Catalogue Number: 2092-4040
• Device Lot Number: G18040018
• 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: 11/01/2018
• Initial Report FDA Received Date: 11/29/2018
• 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