MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 420-006

Device Problem Material Puncture/Hole (1504)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 12/30/2021

Event Type  malfunction  

Manufacturer Narrative

Patient''s date of birth, age unk.Patient''s weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was discarded; thus no investigation could be completed.

Event Description

A peripheral atherectomy procedure commenced to treat a lesion in the patient''s superficial femoral artery (sfa).A spectranetics turbo elite laser atherectomy catheter was used to treat the patient.During the procedure, a pinhole was observed approximately 3 cm away from the luer hub, where the device flush port is located.Laser light was visible shining through the hole.The device was used to finish the procedure with no reported harm to the patient.This event is being reported for unintended radiation exposure, potential for harm.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 13318296
• MDR Text Key: 290456828
• Report Number: 1721279-2022-00009
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)230916(10)FBA21J08A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2023
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA21J08A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• 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: ABBOTT COMMAND GUIDE WIRE SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 6F INTRODUCER SHEATH
• Patient Sex: Male