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

Model Number	2092-4040
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2020
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 above rbp.Recurrence of this malfunction could result in a flow limiting dissection, embolism, or perforation.No patient injury reported.Cross reference mfr report numbers: 3005462046-2020-00014.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Report source: foreign- (b)(6).The angiosculpt device was infectious and discarded by the facility, thus no returned product investigation was performed.The angiosculpt device was used off-label.The ifu states to inflate the balloon 2 atm every 10-15 seconds until full balloon inflation is achieved and to not exceed the rbp printed on the package label.
Event or Problem Description
The angiosculpt device was used in a severely calcified popliteal, p2.The balloon was inflated quickly above the rated burst pressure (rbp) when the balloon ruptured.The user was aware that the device was used outside of the ifu.

• 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: 10261496
• Report Number: 3005462046-2020-00013
• Device Sequence Number: 11529373
• Product Code: PNO
• UDI-Device Identifier: 00813132021405
• UDI-Public: 00813132021405
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2020
• 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: 01/22/2022
• Device Model Number: 2092-4040
• Device Catalogue Number: 2092-4040
• Device Lot Number: G19010027
• 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: 06/29/2020
• Initial Report FDA Received Date: 07/10/2020
• 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