MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT OTW PTA; CATHETER, PTA, CUTTING/SCORING

Model Number	2092-6040
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
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.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 catheter was returned for evaluation.Visual inspection found no unusual characteristics of the device.During functional testing, using an indeflator filled with green color dye water, the device was pressurized up to 10 atm and a leak on the balloon was present.Under microscopic inspection, a longitudinal tear on the proximal portion of the balloon was observed.The user failed to follow instructions.An undersized introducer sheath (5f) was used.The instructions for use indicates the device is compatible with a 6f introducer sheath as indicated on the product label.In addition, the ifu warns at least 99.9% of the balloons (with a 95% confidence level) will not burst at or below the rbp.
Event or Problem Description
The angiosculpt device was used to treat a slightly calcified peripheral lesion.During inflation, the balloon could not be inflated over 10 atm due to a leak on the hub.The procedure was completed with a new angiosculpt device.No patient injury reported.During the returned device evaluation, a balloon rupture was observed.This product problem is being submitted conservatively because the balloon ruptured below rbp.

• Brand Name: ANGIOSCULPT OTW PTA
• Common Device Name: CATHETER, PTA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: ana tan ; 5055 brandin court; fremont, CA 94538
• MDR Report Key: 13539095
• Report Number: 3005462046-2022-00010
• Device Sequence Number: 3734427
• Product Code: PNO
• UDI-Device Identifier: 00813132021436
• UDI-Public: 00813132021436
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 01/05/2022

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: 07/08/2024
• Device Model Number: 2092-6040
• Device Catalogue Number: 2092-6040
• Device Lot Number: G21070007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• 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: 01/26/2022
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• 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: BOSTON SCIENTIFIC: 0.018" FUGA GUIDEWIRE; MEDIKIT: 5F ULTRA HIGH FLOW INTRODUCER SHEATH
• Patient Sex: Unknown