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

Model Number	2076-5040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patent's dob or age at time of event, gender, weight, ethnicity, and race are unknown.This information was not available from the facility.During inflation, the balloon ruptured below rbp.No patient injury, this mdr is being reported conservatively.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Foreign- (b)(6).The angiosculpt device is expected to return.Device evaluation will be performed upon arrival and a supplemental mdr to follow.
Event or Problem Description
The angiosculpt device was used to treat a severely calcified and severely tortuous distal sfa.During the second inflation at 12atm, the balloon ruptured.The procedure was completed with a new angiosculpt device.No patient injury reported.
Additional Manufacturer Narrative
Block d10/g4: the angiosculpt device was returned for evaluation on 12/23/2020.Block h3: visual inspection found a kink on the proximal shaft near the strain relief.During functional testing, the device was pressurized at less than 4 atm and a pinhole leak was observed at the proximal end of the balloon.Block h6: the ifu warns at least 99.9% of the balloons (with a 95% confidence level) will not burst at or below the rbp.

• 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: 11033180
• Report Number: 3005462046-2020-00057
• Device Sequence Number: 1033653
• Product Code: PNO
• UDI-Device Identifier: 00813132021375
• UDI-Public: 00813132021375
• 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,Followup
• Report Date (Section B): 11/30/2020

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: 09/10/2022
• Device Model Number: 2076-5040
• Device Catalogue Number: 2076-5040
• Device Lot Number: G19090008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/11/2021
• 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: ABBOTT: 0.014" COMMAND GUIDE WIRE; MEDIKIT: 7F PARENT CROSS SHEATH/GUIDE
• Outcome Attributed to Adverse Event: Other