MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH

Model Number	560-009
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) pacing lead due to bacteremia.A spectranetics 9f tightrail sub-c device and a lead locking device (lld ez) were utilized to assist with removal of the lead.The lead was prepared by placing the lld ez down in the lead lumen to the tip of the lead, and a braided silk suture was tied around the outer insulation of the lead.The lead and all of the aforementioned components were loaded into the tightrail sub-c device, and the device was utilized to free the lead from binding sites from the entry into the pectoral pocket to the left-brachiocephalic/superior vena cava (svc) junction.The physician desired to switch to a different tool, and attempted to remove the tightrail sub-c from around the lead.Once the tightrail sub-c was removed from the patient (but the lead was still within it), the device became stuck on the lead.The physician could not remove the lead from within the device, and ultimately cut the lead and the lld to free the tool.A silk suture was tied around the remaining components of the lead, and the lead was successfully extracted, using a spectranetics 14f glidelight laser sheath, from the patient without any complications or remnant materials left in the patient.The patient survived the procedure with no reported patient harm.This report is being submitted due to the potential for serious injury if the event were to recur.
Additional Manufacturer Narrative
H6): methods, results and conclusions codes populated now that device evaluation is complete.Device evaluation: on 06 november 2019 a cross-functional engineering team evaluated the returned device.The initial evaluation confirmed the presence of the lld and suture extending from both the distal and proximal end of the device.On 11 november 2019, the team re-inspected the device under x-ray and confirmed that the lead and lld were within the lumen of the device.However, the shaft of the device did not show any signs of damage that would attribute to the experienced failure.During the final evaluation of the device (13 november 2019), the team removed the lld from the proximal end of the tightrail shaft, but the lead remained within the shaft.The hypo-tube shaft was cut in a cross-sectioned manner to facilitate in viewing the lead inside of the tightrail shaft.A visual inspection inside of the shaft lumen determined that the lead size was bigger than the device's inner lumen, which was the cause of the experienced failure of the lead sticking within the tightrail device.H3 other text : placeholder.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: TIGHTRAIL
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9234599
• Report Number: 1721279-2019-00185
• Device Sequence Number: 16741259
• Product Code: DRE
• UDI-Device Identifier: 00813132022785
• UDI-Public: (01)00813132022785(17)210227(10)FRN19B27A
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K161333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019
• Report Date (Section F): 01/01/2005

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: 02/27/2021
• Device Model Number: 560-009
• Device Catalogue Number: 560-009
• Device Lot Number: FRN19B27A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/15/2019
• 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: MEDTRONIC 5086 PACING RV LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005