MAUDE Adverse Event Report: Spectranetics Corporation GlideLight Laser Sheath; Device, Removal, Pacemaker Electrode, Percutaneous

Model Number	500-303
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	09/21/2026
Type of Reportable Event	Serious Injury

• Brand Name: GlideLight Laser Sheath
• Common Device Name: Device, Removal, Pacemaker Electrode, Percutaneous
• 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 ; +1(719)447-2465
• MDR Report Key: 50938355
• Report Number: 3007284006-2026-00461
• Device Sequence Number: 10759926
• Product Code: MFA
• UDI-Device Identifier: 00813132020347
• UDI-Public: (01)00813132020347(17)270721(10)0303530141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960042
• 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): 09/29/2026

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: 500-303
• Device Catalogue Number: 500-303
• Device Lot Number: 0303530141
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 206 LB
• Patient Race: White