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

Model Number	G23749
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicated the information is unknown, unchanged, or unavailable.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 after manufacturer requested for the return." (b)(6).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
A glidelight 14fr was used from the subclavian vein, but there was difficulty in advancing the sheath, and at around the anonymous vein, the glidelight 14fr was shifted to a lr-evn-sh-11.0-rl.After passing through the anonymous vein, the lr-evn-sh-11.0-rl was shifted to the glidelight 14fr.It did not advance from around superior vena cava (svc), right atrium (ra) junction, and the glidelight 14fr was replaced with a glidelight 16fr.The sheath was unable to advance further than around the distal coil of a lead.Though the glidelight 16fr was used with an outer sheath, the situation did not change at all, and the outer sheath got kinked.Then the glidelight 16fr was shifted to lr-evn-13.0-rl and the removal was successfully done.The user noted the slow heart movement to suspect cardiac tamponade.The echo showed pericardial fluid was leaking, therefore the user immediately prepared for drainage and began to suck it out.After watching the patient condition for about 60 minutes, the user and the surgeons determined that bleeding stopped, and then subcutaneous implantable cardioverter-defibrillator (sicd) was placed.
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 after manufacturer requested for the return." e1: title: unknown.E1: postal code: (b)(6).E1: phone number: (b)(6).E3: occupation: 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
A glidelight 14fr was used from the subclavian vein, but there was difficulty in advancing the sheath, and at around the anonymous vein, the glidelight 14fr was shifted to an evolution® shortie rl controlled-rotation dilator sheath set.After passing through the anonymous vein, the evolution® shortie rl controlled-rotation dilator sheath set was shifted to the glidelight 14fr.It did not advance from around superior vena cava (svc), right atrium (ra) junction, and the glidelight 14fr was replaced with a glidelight 16fr.The sheath was unable to advance further than around the distal coil of a lead.Though the glidelight 16fr was used with an outer sheath, the situation did not change at all, and the outer sheath got kinked.Then the glidelight 16fr was shifted to evolution® rl controlled-rotation dilator sheath set and the removal was successfully done.The user noted the slow heart movement to suspect cardiac tamponade.The echo showed pericardial fluid was leaking, therefore the user immediately prepared for drainage and began to suck it out.After watching the patient condition for about 60 minutes, the user and the surgeons determined that bleeding stopped, and then subcutaneous implantable cardioverter-defibrillator (sicd) was placed.The user¿s comment: as the target lead and the glidelight 16fr were not placed coaxially, damage occurred around at the right atrium.The sales rep¿s comment: the fluoroscopy image shows that immediately after the glidelight 16fr was used the heart obviously stopped, and the user thought without doubt that the glidelight 16fr damaged the tissues around the atrium.Nobody noticed that the blood was gradually dropping during the procedure and the heart movement was slow during using the evolution® rl controlled-rotation dilator sheath set.

• Brand Name: LEAD EXTRACTION EVOLUTION SHORTIE 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 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: 22096454
• Report Number: 2522007-2025-00005
• Device Sequence Number: 12729278
• Product Code: DRE
• UDI-Device Identifier: 00827002237490
• UDI-Public: (01)00827002237490(17)280229(10)N213950
• 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: Other,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: G23749
• Device Catalogue Number: LR-EVN-SH-11.0-RL
• Device Lot Number: N213950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BULLDOG¿ LEAD EXTENDER; BULLDOG¿ LEAD EXTENDER; EVOLUTION® RL CONTROLLED-ROTATION DILATOR SHEATH S; EVOLUTION® RL CONTROLLED-ROTATION DILATOR SHEATH S; EVOLUTION® SHORTIE RL CONTROLLED-ROTATION DILATOR; GLIDELIGHT 14 FR; GLIDELIGHT 14FR; GLIDELIGHT 16 FR; GLIDELIGHT 16FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female