MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS QUICK-CROSS SUPPORT CATHETER; CATHETER, PERCUTANEOUS

Model Number	518-037
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	06/14/2021
Type of Reportable Event	Malfunction
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 quick-cross device, 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 10 may 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 14 june 2021.In this procedure on 14 june, the philips representative was present at the procedure.It was identified that the turbo elite 2.3 device''s distal marker band had reportedly detached during the procedure on (b)(6) 2021, not discovered at that time, and during the first fluoroscopic images taken during the 14 june procedure, the marker band was confirmed to be present in the patient''s popliteal artery (please reference mdr #1721279-2021-00124 which captures the turbo elite device in which the marker band reportedly detached and remained 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.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 quick-cross device in which the device''s fluoroscopic markers moved along the catheter shaft but did not detach within the patient.With recurrence, this event has the potential to cause or contribute to serious injury.
Additional Manufacturer Narrative
D9): the quick-cross device was returned to the manufacturer on 20 july 2021.G3): the device evaluation and investigation were completed on 29 july 2021.H6): added codes 10, 3211, 3252, 61.Device evaluation: the device was returned and evaluated by a cross functional team.The shaft was stretched the distal 23cm of the length of the device.The most proximal marker band slid down toward the device''s distal tip, but was still present on the device.The quick-cross device''s lumen likely became stretched from the device getting caught on a lesion or on another device''s marker band (which was present in the patient pre-procedure) and then the quick-cross was pulled during removal from the patient.When the lumen becomes stretched, the device''s marker band does not fit snugly around the lumen, causing the marker band to slide.This has been determined to be a use related failure.

• Brand Name: SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 12163451
• Report Number: 1721279-2021-00125
• Device Sequence Number: 4052831
• Product Code: DQY
• UDI-Device Identifier: 00813132020682
• UDI-Public: (01)00813132020682(17)230105(10)FQQ21A05A
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K033678
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2023
• Device Model Number: 518-037
• Device Catalogue Number: 518-037
• Device Lot Number: FQQ21A05A
• 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: 07/29/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/13/2021
• 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: 0.018 GUIDE WIRE; 6F SHEATH MANUFACTURER UNK; 7F INTRODUCER SHEATH MANUFACTURER UNK; BALLOON MANUFACTURER UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS TURBO ELITE LASER CATHETER
• Patient Age: 72 YR