MAUDE Adverse Event Report: COOK VANDERGRIFT INC. LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	G23746
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	03/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Lead removal was attempted with cook devices (evolution rl controlled-rotation dilator sheath sets and needle's eye snare) and non-cook laser sheaths (14f, 16fr).When the user attempted to remove a long-term placed atrial lead, the blood pressure decreased.The user determined that cardiac tamponade occurred to open the chest.The patient condition after opening the chest is stable.
Additional Manufacturer Narrative
The udi information per 21 cfr 803.52 (c)(4) and 21 cfr 803.50 (b) that is required is reasonably unknown due to the device itself was discarded/not returned for investigation and the lot of the device was unknown.D1: primary udi number: unknown.E1: postal code: (b)(6).E1: phone number: (b)(6).E3: occupation: unknown.G2: other report source: unknown.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 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.
Additional Manufacturer Narrative
The udi information per 21cfr 803.52(c)(4) and 21 cfr 803.50(b) that is required is reasonably unknown due to the device itself was discarded/not returned for investigation and the lot of the device was unknown.D1: primary udi number: unknown.E1: title: unknown.E1: postal code: (b)(6).E1: phone number: (b)(6).E3: occupation: unknown.G2: other report source: unknown.The device was not returned for the complaint; therefore, a physical investigation could not be performed, and the customer's complaint is acknowledged, but could not be confirmed, other than by the customer's testimony.The complaint/event that was entered and reported within trackwise: "cardiac tamponade." the device history record (dhr) was reviewed.There were no signs that the device was nonconforming or that the device was not manufactured to current specifications.This complaint mode will be tracked, trended and monitored in cvi complaint handling and post market surveillance procedures.A risk assessment will be performed within trackwise.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.
Event or Problem Description
Lead removal was attempted with cook devices (evolution rl controlled-rotation dilator sheath sets and needle¿s eye snare) and non-cook laser sheaths (14f, 16fr).When the user attempted to remove a long-term placed atrial lead, the blood pressure decreased.The user determined that cardiac tamponade occurred to open the chest.The patient condition after opening the chest is stable.

• Brand Name: LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VANDERGRIFT INC.; 1186 montgomery lane; vandergrift PA 15690 6065
• Manufacturer (Section G): COOK VANDERGRIFT INC.; 1186 montgomery lane; vandergrift PA 15690 6065
• Manufacturer Contact: timothy vogel ; 1186 montgomery lane; vandergrift, PA 15690-6065 ; 7248458621
• MDR Report Key: 21696336
• Report Number: 2522007-2025-00004
• Device Sequence Number: 18309751
• Product Code: DRE
• UDI-Device Identifier: 10827002237466
• UDI-Public: (01)10827002237466(17)270930(10)N209006
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K141148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: G23746
• Device Catalogue Number: LR-EVN-11.0-RL
• Device Lot Number: N209006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EVOLUTION® RL CONTROLLED-ROTATION DILATOR SHEATH S.; LASER SHEATH 14F.; LASER SHEATH 16FR.; LR-EVN-13.0-RL.; LR-EVN-SH-9.0-RL.; LR-NES001.; LR-TSS-11.0.; NEEDLE¿S EYE SNARE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown