MAUDE Adverse Event Report: COOK VANDERGRIFT INC. LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET; GCC, DILATOR, CATHETER

Model Number	G19859
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was received from merit medical on behalf of the user facility: a male patient in his 50s with a persistent left superior vena cava (plsvc) had an atrial lead and a ventricular lead implanted via the right subclavian vein.The ventricular lead was a dual-coil defibrillation lead positioned in the middle cardiac vein.Both leads were screw-in leads.The procedure was performed to replace only the atrial lead.The atrial lead was grasped near its tip using a needle's eye snare (nes002), followed by extraction with an evolution shortie (evnsh11).A 14 fr laser sheath and subsequently a byrd dilator sheath (pplbes 10 fr sheath) were then utilized, and the atrial lead was successfully removed.After the extraction, while attempting to implant a new atrial lead, pericardial effusion was observed.Pericardial drainage was performed, and the patient's condition stabilized.Therefore, surgical intervention via thoracotomy was not required.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, not applicable, or not available.D3: usa e1: jpn g1: usa the event is currently under investigation.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of the investigation.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET
• Common Device Name: GCC, DILATOR, CATHETER
• Manufacturer (Section D): COOK VANDERGRIFT INC.; 1186 montgomery lane; vandergrift PA 15690 -606
• Manufacturer (Section G): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690 -606
• Manufacturer Contact: kimberly platt ; 1186 montgomery lane; vandergrift, PA 15690--606 ; +1(724)845-8621
• MDR Report Key: 50094063
• Report Number: 2522007-2026-00013
• Device Sequence Number: 18761657
• Product Code: GCC
• UDI-Device Identifier: 00827002198593
• UDI-Public: 00827002198593
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K893480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: G19859
• Device Catalogue Number: LR-PPLBES-10.0
• Device Lot Number: N216846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 14Fr Laser; Evolution Shortie 11 - Cook Medical; Needle¿s Eye Snare - Cook Medical
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male