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

Model Number 420-159

Device Problem Break (1069)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

Patient''s date of birth, age unk.Patient''s gender unk.Patient''s weight unk.Patient''s ethnicity/race unk.Other relevant history unk.The device was discarded, thus no investigation could be completed.From photo provided, it has been confirmed that a breach in the device''s outer jacket and exposed fibers had occurred, causing unintended radiation exposure.The cause of the device damage could not be established.

Event Description

A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the patient''s mid superficial femoral artery (sfa).A spectranetics turbo elite laser atherectomy catheter was chosen to treat the patient.During use in the patient, the device''s outer jacket had separated and no longer covered the fibers and inner lumen of the catheter.A new turbo elite of the same model was used to successfully complete the procedure with no reported patient harm.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): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 14569216
• MDR Text Key: 300779163
• Report Number: 1721279-2022-00103
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)240330(10)FBH22C23A
• 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: 06/01/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2024
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH22C23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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: 6F INTRODUCER SHEATH MANUFACTURER UNK; COOK MEDICAL ROADRUNNER 0.014 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM