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

Model Number	545-513
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's date of birth unk.Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.From the complaint narrative and the photos provided, this failure has been determined to be use related.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to lead dysfunction.A spectranetics lead locking device (lld) was inserted into the lead to provide traction.The physician used a spectranetics 13f tightrail rotating dilator sheath and successfully removed the lead.The physician customarily pulls the freed lead out of the proximal end of the tightrail device.In this event, it was difficult to remove the lead out the proximal end, and when the lead was removed from the proximal end after the tightrail device was out of the patient's body, the inner mechanism of the tightrail device came out with the lead.The inner mechanism was wrapped around the lead and stretched, confirmed by photos provided to the manufacturer.The procedure was completed with no patient harm and no intervention was required.This report captures the tightrail device in use when the inner mechanism of the device came out the proximal end along with the lead, with a potential for harm with recurrence.

• 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
• MDR Report Key: 12674772
• Report Number: 1721279-2021-00194
• Device Sequence Number: 1507136
• Product Code: DRE
• UDI-Device Identifier: 00813132020897
• UDI-Public: 00813132020897
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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 Model Number: 545-513
• Device Catalogue Number: 545-513
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/21/2021
• 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: BOSTON SCIENTIFIC RV ICD LEAD MODEL UNK; SPECTRANETICS LEAD LOCKING DEVICE
• Patient Age: 66 YR
• Patient Weight: 78