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

Model Number	560-011
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	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2): patient''s date of birth, age unk h3): the device was discarded, thus no investigation could be completed.H6): the cause of the tightrail sub-c likely cutting the lv lead/lld could not be established.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) and a left ventricular (lv) lead due to lead fracture.A right atrial (ra) lead was present in the patient as well, but was not initially targeted for extraction.Spectranetics lld ez lead locking devices (lld ezs) were inserted into the rv and lv leads to provide traction.Beginning with a spectranetics 11f tightrail sub-c rotating dilator sheath on the lv lead, it appeared the tightrail cut the lv lead and lld in the subclavian region.Switching efforts to the rv lead, multiple spectranetics devices were used (glidelight laser sheath, visisheath dilator sheath, tightrail (long) rotating dilator sheath) to attempt removal, but were unsuccessful.It was determined the ra lead required removal, due to lead on lead binding to the rv and lv leads.An lld ez was inserted into the ra lead to provide traction, and multiple devices were used to achieve successful removal of the lead.Then, switching efforts to the rv lead again, lead removal was achieved.Removal of the lv lead/lld remnants was not attempted, and because the lld was likely cut by the tightrail sub-c, it could not be unlocked from the lv lead.The lv lead/lld were capped and remained in the patient (mdr #3007284006-2024-00021).The patient survived the procedure.This report captures the 11f tightrail sub-c which likely cut the lv lead/lld in the procedure.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
There was no adverse event.The tightrail sub-c did not malfunction during the procedure.However, it likely cut the lv lead/lld which can result in potential for harm with recurrence.Corrected from adverse event to product problem.Corrected reference mdr # from 3007284006-2024-00021 to 3007284006-2024-00023.Corrected from serious injury to malfunction.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) and a left ventricular (lv) lead due to lead fracture.A right atrial (ra) lead was present in the patient as well, but was not initially targeted for extraction.Spectranetics lld ez lead locking devices (lld ezs) were inserted into the rv and lv leads to provide traction.Beginning with a spectranetics 11f tightrail sub-c rotating dilator sheath on the lv lead, it appeared the tightrail cut the lv lead and lld in the subclavian region (mdr #3007284006-2024-00022).Switching efforts to the rv lead, multiple spectranetics devices were used (glidelight laser sheath, visisheath dilator sheath, tightrail (long) rotating dilator sheath) to attempt removal, but were unsuccessful.It was determined the ra lead required removal, due to lead on lead binding to the rv and lv leads.An lld ez was inserted into the ra lead to provide traction, and multiple devices were used to achieve successful removal of the lead.Then, switching efforts to the rv lead again, lead removal was achieved.Removal of the lv lead/lld remnants was not attempted, and because the lld was likely cut by the tightrail sub-c, it could not be unlocked from the lv lead.The lv lead/lld were capped and remained in the patient (mdr #3007284006-2024-00023).The patient survived the procedure.This event is being reported in an abundance of caution to capture the 11f tightrail sub-c which likely cut the lv lead/lld in the procedure, potential for harm.There was no alleged malfunction of this tightrail sub-c or any spectranetics devices in use during the procedure.

• Brand Name: TIGHTRAIL SUB-C ROTATING DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 18636233
• Report Number: 3007284006-2024-00022
• Device Sequence Number: 7763413
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: (01)00813132022792(17)241206(10)FRP22M06A
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161333
• 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,Followup
• Report Date (Section B): 02/02/2024

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: 12/06/2024
• Device Model Number: 560-011
• Device Catalogue Number: 560-011
• Device Lot Number: FRP22M06A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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: MEDTRONIC 4398 LV LEAD; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6935M RV ICD LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Sex: Male
• Patient Weight: 160 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American