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

Model Number	G23746
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was received from merit medical on behalf of the user facility: extraction procedure of an a-lead ((b)(6)) that had been in place for approximately 10 years.When the evolution (evo11) was advanced to the j-curve of the lead, the tip of the lead became detached.Subsequently, the patient developed hypotension, and an open thoracotomy was performed.A laceration was found around the right atrium superior vena cava (ra-svc) junction.After the thoracotomy, the chest was closed, and the patient was transferred out of the operating room.
Additional Manufacturer Narrative
D3: usa d4: 11/30/2028 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 EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION
• 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: 50098689
• Report Number: 2522007-2026-00014
• Device Sequence Number: 13329925
• Product Code: DRE
• UDI-Device Identifier: 10827002237466
• UDI-Public: (01)10827002237466(17)281130(10)N223260
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,Health Professional,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: G23746
• Device Catalogue Number: LR-EVN-11.0-RL
• Device Lot Number: N223260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/03/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown