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

Model Number	423-001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's age, date of birth unavailable.Patient's weight unavailable.Device was evaluated by manufacturer; the initial device evaluation is captured in the narrative below.(b)(4).Device evaluation: the device was returned to the manufacturer and was evaluated on 20 may 2021 by a cross functional team.The device itself was returned; however, the distal marker band was not returned.Slight erosion was noted on the distal tip of the device.There were two dead fibers present at the distal tip (within spec).A side view of the device was performed.Initial investigation determined the cause of the event was due to due a circumferential void located at the locking feature of the device's distal band.This void may have prevented the epoxy from locking the distal marker band into place which allowed the band to become detached during the procedure.However, the investigation continues and a supplemental mdr will be submitted after the final investigation has been completed, and will contain investigation findings and investigation conclusion codes.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a lesion within an existing stent in a popliteal artery.It was reported that the physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient.It was reported that on the 3rd pass through the lesion with the catheter, the device's distal marker band dislodged within the patient''s popliteal artery.The marker band was successfully removed by using a balloon.There was no reported patient harm.The device was returned to the manufacturer for evaluation.The initial device evaluation is captured within section 10./11.
Additional Manufacturer Narrative
H6): added component code 943 and heic code 2199.H6): the final investigation for this event was completed 16 july 2021 and as a result the investigation findings codes and investigation conclusion code have now been populated.This event has been determined to be production process related.

• 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: 11896296
• Report Number: 1721279-2021-00101
• Device Sequence Number: 14373920
• Product Code: MCW
• UDI-Device Identifier: 00813132024772
• UDI-Public: (01)00813132024772(17)230112(10)FBC20M27A
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: 01/12/2023
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC20M27A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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: 2MM BALLOON MANUFACTURER UNKNOWN; DESTINATION 7F 45MM SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Other