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

Model Number	501-116
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Great Vessel Perforation (2152); Pericardial Effusion (3271)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to fracture.A spectranetics lld lead locking device (lld) was attempted to be inserted onto the lead to provide traction, but was unsuccessful.Beginning with a spectranetics 16f glidelight laser sheath, along with a spectranetics large visisheath dilator sheath, advancement was made down the lead, but stalled at the distal end of the proximal coil.When removing the devices, the patient's blood pressure dropped and a pericardial effusion was detected via transesophageal echocardiography (tee), and it was suspected there was a superior vena cava (svc)/innominate junction perforation.Medication was administered; however, did not stabilize the patient immediately.After some time, the patient's blood pressure increased, and the injury clotted and healed.The decision was made to abandon the lead to extract at a later date; therefore, the patient was monitored and sent for imaging.The patient survived the procedure.This report captures the visisheath in use when the perforation occurred, requiring intervention.There was no alleged malfunction of the spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
A3b) patient gender - not available from facility.A4) patient weight - not available from facility.H3) the visisheath was discarded, thus no product investigation was performed.H6) per ifu, perforation is listed as a potential adverse event with use of the visisheath device.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.

• 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: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 24783462
• Report Number: 3007284006-2026-00115
• Device Sequence Number: 9904702
• Product Code: DRE
• UDI-Device Identifier: 00813132020408
• UDI-Public: (01)00813132020408(17)280107(10)0303667893
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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 Model Number: 501-116
• Device Catalogue Number: 501-116
• Device Lot Number: 0303667893
• 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: 03/11/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2026
• 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 6944 RV ICD LEAD.; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LLD LEAD LOCKING DEVICE.
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White