MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	545-511
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded, thus no investigation could be completed.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead, extraction indication unk.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The ra lead was extracted with no reported issue.The physician was attempting to extract the rv lead using a spectranetics 11f tightrail rotating dilator sheath when the tightrail device became stuck on the lead, with the shaft of the device stuck within the patient.This necessitated the tightrail device (and the portion of the lead within the tightrail device) to be cut and disassembled to remove it from within the patient.All components of the tightrail device were removed from the patient, and the remainder of the rv lead was extracted from the femoral vein with a snare.The tip of the rv lead broke off from the rv lead remnant during the snaring attempt, but the lld which was present in the lead was removed in its entirety.This report captures the tightrail device present on the rv lead when it became stuck on the lead, requiring intervention for lead removal.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 13317168
• Report Number: 1721279-2022-00008
• Device Sequence Number: 3386523
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)231102(10)FRK21L02A
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K150360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2021

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: 11/02/2023
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK21L02A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEMORAL SNARE MANUFACTURER UNK; RA LEAD: TYPE MANUFACTURER AND MODEL UNK; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1888TC RV PACING LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown