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

Model Number	410-154
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded, thus no investigation could be completed.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a slightly calcified plaque lesion in the proximal common femoral artery (cfa).The physician used a spectranetics turbo elite laser atherectomy catheter to treat the patient.The turbo elite was inserted into the outer sheath where resistance was felt by the operating physician; it was difficult to pull the catheter back out.Once the turbo elite was removed from the outer sheath, it was discovered that the catheter was split open and the wires (fibers) inside the catheter were exposed.The turbo elite was discarded and another turbo elite was used to successfully complete the case 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: 14318176
• Report Number: 1721279-2022-00083
• Device Sequence Number: 4661093
• Product Code: MCW
• UDI-Device Identifier: 00813132024703
• UDI-Public: (01)00813132024703(17)240208(10)FBE22A25A
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

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: 02/08/2024
• Device Model Number: 410-154
• Device Catalogue Number: 410-154
• Device Lot Number: FBE22A25A
• Was Device Available for Evaluation?: No
• 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: 04/20/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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 ANSEL 6F INTRODUCER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO RUNTHROUGH 0.014 GUIDE WIRE
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 87 KG