MAUDE Adverse Event Report: SPECTRANETICS CORPORATION VISISHEATH DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	501-014
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2): patient''s date of birth unk.A4): patient''s weight unk.A5a./5b.): patient''s ethnicity/race unk.B7): other relevant history unk.H3/h6): the device was discarded, thus no investigation could be completed and the cause of the reported failure 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 bacteremia.Using simple traction only, the lv lead was removed successfully.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath and a spectranetics visisheath dilator sheath, pressure was applied to the visisheath as it advanced over the glidelight in the subclavian/innominate regions.After progress stalled within the vasculature, the glidelight and visisheath were removed, and it was observed that the distal end of the visisheath was bent and frayed.A new visisheath was used with the same glidelight, the rv lead was removed, and the procedure was completed with no reported patient harm.This report is being submitted conservatively for the visisheath frayed distal tip (possible sharp edge), potential for harm with recurrence.

• Brand Name: VISISHEATH 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: 18899254
• Report Number: 3007284006-2024-00057
• Device Sequence Number: 6410944
• Product Code: DRE
• UDI-Device Identifier: 00813132020361
• UDI-Public: (01)00813132020361(17)250712(10)FVM23G12A
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K092378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

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: 07/12/2025
• Device Model Number: 501-014
• Device Catalogue Number: 501-014
• Device Lot Number: FVM23G12A
• 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
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• 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 0185 RV ICD LEAD.; BOSTON SCIENTIFIC 4543 LV LEAD.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICE.
• Patient Age: 72 YR
• Patient Sex: Male