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

Model Number	2076-4020
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The angiosculpt device was used to treat a slightly calcified peripheral lesion.After inflation and during removal, resistance was encountered, and the scoring element separated from the balloon.The balloon and guide wire were removed as a unit.The scoring element was removed using a radial jaw and confirmed by echo that no device fragments remained in the patient.The procedure was completed with a non-angiosculpt catheter.The patient expired the following day; however per the physician, the patient death was unrelated to the angiosculpt catheter.This adverse event and product problem is being submitted due to the scoring element separation requiring additional intervention for removal.
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.This was not reported for "death" since the physician stated that the patient death was unrelated to the angiosculpt catheter.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 catheter was returned without the distal tip, distal bond, scoring element, and intermediate bond.Visual inspection found damage at the distal end of the catheter where the exposed extrusion material at the distal tip was bonded.During functional testing, a laboratory 0.018" guide wire was unable to be inserted through the guide wire lumen due to the damage observed at the distal end of the catheter.Based on the device evaluation, it is likely that some degree of force was applied by the user resulting in the scoring element separation.Per the ifu, retained device components is listed as a possible adverse effects of the procedure.

• 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; 5055 brandin court, CA 94538
• MDR Report Key: 13099430
• Report Number: 3005462046-2021-00074
• Device Sequence Number: 11264515
• Product Code: PNO
• UDI-Device Identifier: 00813132021344
• UDI-Public: 00813132021344
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2022
• Device Model Number: 2076-4020
• Device Catalogue Number: 2076-4020
• Device Lot Number: G19080032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• 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: 12/06/2021
• Initial Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2019
• 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: ASAHI: 0.018" TREASURE GUIDE WIRE; MEDIKIT: 6F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown