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

Model Number	410-152
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's date of birth, age unk.Patient's gender unk.Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was returned to the manufacturer on 22 feb 2022.The device evaluation and investigation were completed on 03 mar 2022.Device evaluation: the device was returned and evaluated by a cross functional team.No damage was seen to the device's tail tube.Kinks were seen on the device's working length at 14, 17 and 19 inches from the bifurcate.At 14 and 17 inches from the bifurcate, broken fibers and breaches to the outer jacket were visible.Approximately half of the fibers were dead at the device's distal tip and proximal coupler.Calibration was not attempted due to the breaches seen in the outer jacket.There were not enough biologics present on the device to determine if the device had entered the body.Based on the device evaluation and investigation, it could not be determined when or how the kinks, breaches and broken fibers occurred.
Event or Problem Description
A peripheral atherectomy procedure commenced, indication for procedure/location of procedure unk.The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient.It was reported that the turbo elite device did not calibrate, so a second turbo elite device, same model, was used to successfully complete the procedure with no reported patient harm.However, during device evaluation on 03 mar 2022, it was discovered that kinks, broken fibers and breaches to the device's outer jacket were present on the device's working length.This report captures the turbo elite which was found to have kinks, broken fibers and breaches to the outer jacket, causing unintended radiation exposure, potential for harm.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: 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: 13955823
• Report Number: 1721279-2022-00060
• Device Sequence Number: 11989734
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)231006(10)FBD21J30A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2022

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: 10/06/2023
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD21J30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• 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: 03/03/2022
• Initial Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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: GUIDE CATHETER MANUFACTURER AND SIZE UNK; GUIDE WIRE MANUFACTURER AND SIZE UNK; INTRODUCER SHEATH MANUFACTURER AND SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Sex: Unknown