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

Model Number	2092-6040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient'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.Cross reference mfr report numbers: 3005462046-2021-00040.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Report source: foreign country (b)(6).The angiosculpt device was discarded by the facility, thus no returned product investigation was performed.
Event or Problem Description
The angiosculpt device was used to treat the peripheral lesion.During the third inflation at 8 atm for 10 seconds, the balloon ruptured.The procedure was completed with a new angiosculpt device.No patient injury reported.
Additional Manufacturer Narrative
Block d4: corrected lot number from g20050001 to g18120001 and the expiration date from 5/1/2023 to 12/3/2021.Block h4: corrected device manufacture date from 5/1/2020 to 12/3/2018.

• 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
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: diana melliza galvez ; 5055 brandin court; fremont, CA 94538
• MDR Report Key: 12125365
• Report Number: 3005462046-2021-00041
• Device Sequence Number: 3592637
• Product Code: PNO
• UDI-Device Identifier: 00813132021436
• UDI-Public: 00813132021436
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K100303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 12/03/2021
• Device Model Number: 2092-6040
• Device Catalogue Number: 2092-6040
• Device Lot Number: G18120001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F INTRODUCER SHEATH MFG UNK; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE
• Patient Sex: Unknown