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

Model Number	2076-6040
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	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inflation, the balloon ruptured above rbp.Recurrence of this malfunction could result in an embolism, flow limiting dissection, or perforation.No patient injury reported.  cross reference mfr report number: 3005462046-2020-00025.The angiosculpt device was returned for evaluation.Visual inspection found an inverted balloon at the distal end and the distal bond was damaged with 2 leaflets lifted, but remained intact to the device.During functional testing, using an indeflator filled with warm water, the balloon was pressurized at less than 2 atm and a pinhole leak was observed in the center of the balloon.The angiosculpt device was used off-label.The ifu warns to not exceed the rated burst pressure as indicated on the product label.In addition, an undersized guide catheter (4f) was used.The product label indicates the angiosculpt device is compatible with a 6f guide catheter.
Event or Problem Description
The angiosculpt device was used in a severely calcified distal sfa.During the second or third inflation, the balloon ruptured at 16 atm (rbp is 14 atm).The procedure was completed with a competitor 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: 10462766
• Report Number: 3005462046-2020-00024
• Device Sequence Number: 16846251
• Product Code: PNO
• UDI-Device Identifier: 00813132021399
• UDI-Public: 00813132021399
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• 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): 08/06/2020
• 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: 10/30/2022
• Device Model Number: 2076-6040
• Device Catalogue Number: 2076-6040
• Device Lot Number: G19100056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• 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: 08/06/2020
• Initial Report FDA Received Date: 08/27/2020
• 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
• Patient Age: 73 YR
• Patient Weight: 98
• Date Report Sent to FDA: 01/01/2005