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

Model Number	501-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv), right atrial (ra), and left ventricular (lv) lead due to bacteremia.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Utilizing a spectranetics glidelight laser sheath, the ra and lv lead were removed successfully.Then, switching to a spectranetics 11f tightrail rotating dilator sheath, along with a spectranetics large visisheath dilator sheath on the rv lead, progress stalled at the superior vena cava (svc)/ra junction.While upsizing to a spectranetics 13f tightrail rotating dilator sheath, the patient¿s blood pressure dropped, and a pericardial effusion was detected via transesophageal echocardiogram (tee).Rescue efforts began, including sternotomy.An svc/ra junction perforation was discovered and repaired.The decision was made to abandon the extraction procedure; therefore, the lld ez, along with the rv lead, were cut/capped and remained in the patient (mdr#: 3007284006-2026-00066).There was no attempt made to unlock the lld ez.The patient survived the procedure.This report captures the visisheath in use when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
B6) relevant tests/laboratory data - 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.

• 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: 24548238
• Report Number: 3007284006-2026-00064
• Device Sequence Number: 9485873
• Product Code: DRE
• UDI-Device Identifier: 00813132020378
• UDI-Public: (01)00813132020378(17)271217(10)0303660760
• 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): 03/09/2026

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: 501-016
• Device Catalogue Number: 501-016
• Device Lot Number: 0303660760
• 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: 02/13/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2025
• 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: BIOTRONIK 377176 RA PACING LEAD.; BIOTRONIK 395723 RV ICD LEAD.; BIOTRONIK 408718 LV LEAD.; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATH.; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Hispanic
• Patient Race: White