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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove right atrial (ra) and right ventricular (rv) leads, both capped, and an active rv lead as well, due to cied system/pocket infection.The center lumens of the capped ra and rv leads were compromised, fractured years ago, so a traction platform could not be established.A spectranetics lead locking device (lld) was inserted into the active rv lead to provide traction.Along with other devices, the physician used a spectranetics tightrail rotating dilator sheath to aid in extraction.As the physician was working on the active rv lead using the tightrail device, the active rv lead (with lld inside) and both capped leads were sheared off in the innominate area by the tightrail device (mdr #1721279-2022-00063).The physician could not maintain traction to keep the tightrail coaxial due to the leads unraveling, and the active rv lead doubled over itself, causing it to be cut.The leads were adhered together, so the physician did not try any other means to remove them.The lld was capped within the active rv lead and remained in the patient (mdr #1721279-2022-00064).The physician referred the patient to the cardiothoracic (ct) surgeon for a consult to decide if she needed an open procedure to remove the leads.The patient sustained no injury and survived the lead extraction attempt.This report captures the tightrail device which inadvertently sheared off all three leads, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
The device was discarded, thus no investigation could be completed.The cause of this event was not as a result of the tightrail device; fractured/adhered leads present within the patient kept the physician from being able to remain coaxial with the tightrail device.

• 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): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 14092467
• Report Number: 1721279-2022-00063
• Device Sequence Number: 20057377
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)231116(10)FRK21L16A
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/15/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK21L16A
• 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: 03/15/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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: BOSTON SCIENTIFIC 0672 CAPPED RV ICD LEAD; BOSTON SCIENTIFIC 0672 RV ICD LEAD; BOSTON SCIENTIFIC 4063 CAPPED RA PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American