MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION ANGIOSCULPT RX PTCA; CATHETER, PTCA, CUTTING/SCORING

Model Number 2200-3010

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: the angiosculpt device was returned in two pieces.Visual inspection found a damaged and stretched distal shaft, damaged proximal bond, and a lacerated rx port.The separation at the intermediate shaft exposed the sharp tip of the core wire, however the core wire is a malleable material.No missing pieces, all parts of the device were accounted for.Per the physician comment, the tortuous angle may have caused the shaft issue and resistance.Per the ifu, retained device component is listed as a possible adverse effects of the procedure.The angiosculpt device is indicated for use in the coronary lesion; however, the device was used off-label in a peripheral procedure.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

The angiosculpt coronary device was used off-label in a peripheral procedure to treat a calcified and tortuous distal at.Upon removal, resistance was noted and the device separated at the distal shaft.All parts were retrieved using a non-philips balloon inflated to low pressure and pulled back into the sheath.Angiogram and fluoroscopy confirmed no device fragment was left in the patient.The procedure was completed with the suspect device with no patient complications reported.The physician thought that the tortuous angle caused the shaft issue and resistance.This adverse event and product problem is being submitted due to the shaft separation requiring medical intervention for removal.

• Brand Name: ANGIOSCULPT RX PTCA
• Type of Device: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 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: 15810783
• MDR Text Key: 303797564
• Report Number: 3005462046-2022-00054
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021207
• UDI-Public: 00813132021207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2024
• Device Model Number: 2200-3010
• Device Catalogue Number: 2200-3010
• Device Lot Number: G21030080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASAHI: 0.014" GLADIUS MONGO GUIDEWIRE; FLEXOR: 6F ANSEL INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 39 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White