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

Model Number	414-159
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	05/18/2022
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 and evaluated by a cross functional team.There was an obvious 1 inch breach to the outer jacket beginning 2 inches from the distal tip.In the area of the breach, the fibers, mandrel and inner lumen were exposed, with the mandrel discovered broken into two pieces.However the mandrel was still contained within the device's' working length, with the broken edges observed in the area of the breach.There were no broken fibers observed in the area of the breach.The guide wire port was in good working condition.During use, the outer jacket may have become caught on calcification or other patient anatomy causing the breach; however, it could not be confirmed how or when the breach to the jacket occurred.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a slightly calcified, plaque lesion in the patient's distal posterior tibial artery.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.After the treatment had been completed, the turbo elite was removed from the outer sheath and the physician noticed the fibers of the turbo elite were exposed.The procedure was completed 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
• 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: 14688935
• Report Number: 1721279-2022-00105
• Device Sequence Number: 6692467
• Product Code: MCW
• UDI-Device Identifier: 00813132024727
• UDI-Public: (01)00813132024727(17)240406(10)FBF22D04A
• 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): 06/14/2022

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: 04/06/2024
• Device Model Number: 414-159
• Device Catalogue Number: 414-159
• Device Lot Number: FBF22D04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• 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: 05/18/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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: COOK MEDICAL 5F INTRODUCER SHEATH.; GUIDE WIRE MANUFACTURER/SIZE UNK,; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM,
• Patient Sex: Unknown