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

Model Number	G23737
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	08/04/2025
Type of Reportable Event	Serious Injury
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 at this time.D1 - primary udi number: unknown, e1 - title: unknown, e1 - postal code: unknown, e1 - phone number: unknown, e3 - occupation: 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.
Event or Problem Description
The lr-evn-9.0-rl was removed by manipulating it little by little in the coronary sinus (cs).After removal, pericardial fluid gradually accumulated, and blood pressure dropped from 80 to 50.However, it quickly recovered with fluid infusion and vasopressors.Cardiac tamponade was suspected, so drainage was considered.As there was not enough fluid to allow puncture, a request was made to the surgeon, who opened the epigastrium and performed drainage.It was thought that a partial thrombus had already formed and the bleeding had stopped naturally.There is likely damage somewhere in the cs, but the injury was caused by the product or by removing the lead, and the cause of the complication is not clear.There was no extension of hospital stay or disability.

• 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 -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 ; 7248458621
• MDR Report Key: 23009470
• Report Number: 2522007-2025-00019
• Device Sequence Number: 21459803
• Product Code: DRE
• UDI-Device Identifier: 10827002237374
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

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: G23737
• Device Catalogue Number: LR-EVN-9.0-RL
• Device Lot Number: N214106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown