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

Model Number	414-151
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer anticipates return of the turbo elite device for evaluation, but has not received it at this time.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the proximal peroneal artery.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.According to the report, calibration was normal, and then at initial flush of the device, resistance was felt and a guide wire could not easily pass through the turbo elite catheter.However, ultimately it did work, and the physician lased a small portion within the peroneal artery without trouble.After the catheter was removed from the patient, on visual inspection the team saw red light emitting from the catheter at approximately one meter from the device's distal tip.The report stated that the catheter was probably already broken before the first laser attempt, explaining the flush and guide wire resistance, but the team did not see the red light at that time.Once the red light was seen emitting from the catheter, use of the device was discontinued and the procedure was completed with percutaneous transluminal angioplasty (pta) and another turbo elite device, used on low settings with no reported patient harm.This event is being reported due to unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
B5: this event is no longer reportable per the device analysis results.D9: the device was received by the manufacturer on 06 oct 2021.H3: the device evaluation was completed on 07 oct 2021.H6: in the initial mdr, hecc code 4565 was used, based on the information the manufacturer received in the initial complaint report.However, after the device evaluation and investigation were completed, this code has been corrected to 4582 (see device evaluation below).Added component code 772.H6: device evaluation: the device was returned and evaluated by a cross functional team.Kinks and wrinkles were seen on the device''s outer jacket, 27.5 in from the device''s distal tip.When the device was plugging into the simulated laser light, multiple broken fibers were observed under the device''s outer jacket.However, no breach to the jacket was observed.Looking at the distal tip, 8-10 dead fibers were seen.The kinks and wrinkles observed on the device in addition to the broken fibers observed are determined to be use related.
Event or Problem Description
This event is no longer reportable for potential exposure to manufacturing materials and unintended radiation exposure.Per the returned device analysis, no breach to the outer jacket was observed.This event did not result in patient harm nor would it cause or contribute to patient harm with recurrence.

• 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
• MDR Report Key: 12207879
• Report Number: 1721279-2021-00136
• Device Sequence Number: 4412201
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)210905(10)FAY19H21A
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 09/05/2021
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY19H21A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.014 GUIDE WIRE MANUFACTURER UNK; 6F INTRODUCER SHEATH MANUFACTURER UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TURBO ELITE 1.7 LASER ATHERECTOMY CATHETER; 0.014 GUIDE WIRE MANUFACTURER UNK; 6F INTRODUCER SHEATH MANUFACTURER UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TURBO ELITE 1.7 LASER ATHERECTOMY CATHETER