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	Foreign Body Embolism (4439)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight unavailable.Relevant tests/laboratory data not available from facility.Other relevant history not available from facility.The manufacturer is anticipating return of the marker band, but has not received it at this time.
Event or Problem Description
A philips representative became aware on 14 june 2021 of a peripheral atherectomy procedure, performed (b)(6) 2021 in which the physician used a spectranetics 2.3 turbo elite laser atherectomy catheter.Although the representative was not at the procedure, it was reported that treatment of a stenosis or lesion was being performed in a moderately fibrous area in the popliteal artery.At the time of the (b)(6) procedure, there were no reported issues and the procedure was completed.However, after the procedure, it was reported that the patient''s symptoms did not resolve and so a duplex scan was performed.The scan showed "something had shut down", but they were not sure what, so a subsequent procedure was performed on (b)(6) 2021.In this procedure on (b)(6), the philips representative was present at the procedure.It as identified that the turbo elite 2.3 device''s distal marker band had reportedly detached during the procedure on (b)(6), not discovered at that time, and during the first fluoroscopic images taken during the (b)(6) procedure, the marker band was confirmed to be present in the patient''s popliteal artery.The physician utilized a spectranetics quick-cross support catheter to begin to treat the patient.Once the quick-cross catheter reached the popliteal artery, it was reported that the quick-cross''s fluoroscopic markers (present on the catheter) moved along the catheter shaft but did not separate fully from the catheter and the markers did not remain in the patient (please reference mdr #1721279-2021-00125 which captures the quick-cross catheter in which the fluoroscopic markers moved along the catheter shaft).The team believed the markers moved because they experienced friction while in contact with the distal marker band that was present in the popliteal artery.The quick-cross device was removed, and they continued with the procedure by using a spectranetics 2.0 turbo elite laser atherectomy catheter through the popliteal artery and into the posterior tibial artery.Along the way, the previous 2.3 marker band advanced forward with the laser actively running, and while removing the 2.0 turbo elite device, the 2.3 marker band backed up the artery of the patient, and remained on the tip of the 6f sheath that was also being used in the procedure.The physician inserted a balloon through the 2.3 marker band remaining in the patient and was able to back the marker band, the sheath and the balloon out of the patient, while successfully maintaining guide wire access.The rest of the intervention procedure was completed successfully and the patient survived the procedure with no reported injury.This report is being submitted to capture the 2.3 turbo elite device''s distal marker band that was retained in the patient during the procedure on (b)(6) 2021.On (b)(6) 2021, additional intervention was performed to remove the distal marker band from the patient.
Additional Manufacturer Narrative
D9): the device''s marker band was returned to the manufacturer on 20 july 2021.G3): the device evaluation and investigation were completed on 04 aug 2021.H3): device evaluation: the marker band of the turbo elite was returned and evaluated by a cross functional team.The marker band for this device is manufactured by a supplier.There were no cracks seen on the marker band.Additionally, no excessive epoxy was seen on the internal surface of the band.A mold was created and measurements were taken of the internal surface of the marker band.The external groove was not measured because the groove had been polished off.The distance to the edge of the locking feature could not be measured because the edge of the locking feature did not exist.The locking feature was shifted to the edge of the part instead of being 0.015¿ from the edge of the part.The inner and outer diameter of the marker band were within specifications.This failure is determined to be supplier 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: 12163477
• Report Number: 1721279-2021-00124
• Device Sequence Number: 4052832
• 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: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 07/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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: GUIDE WIRE MANUFACTURER UNK.; INTRODUCER SHEATH MANUFACTURER UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR