MAUDE Adverse Event Report: COOK VANDERGRIFT INC. LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET; DRB STYLET, CATHETER

Model Number	G26550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Intraoperative Cardiac Injury (4855)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to cook japan from the user facility: a screw-in right ventricle (rv) lead was fitted with a liberator beacon tip locking stylet (lr-ofa01), and during dissection with a 16f laser (manufactured by another company), the patient¿s blood pressure dropped.Cardiopulmonary resuscitation (cpr) was performed, and an open-chest surgery was conducted, during which a defect was found near the right atrium (ra) ¿superior vena cava (svc) region.The defect was repaired, and the patient was transferred to the intensive care unit (icu).Although approximately 3 cm of the lead tip remained, the rest of the lead and lr-ofa01 were removed.Regarding the retained lead tip, it was determined by the physician that no additional removal procedure would be performed.According to the physician, the laser (non-cook device) used for lead stripping was considered to be the direct cause of the reported event.Additional information was later provided to a cook sales representative, indicating the patient remained in the icu and was unable to be weaned from the percutaneous cardiopulmonary support (pcps) system.
Additional Manufacturer Narrative
The following blank field was available: e1 - zip code/postal code: (b)(6).The device was not returned for evaluation due to the device being discarded by the user facility; 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.There was no allegation or evidence of a device malfunction of a cook product.Per the complaint details and provided responses, it was reported that the 16f laser used for lead stripping was the direct cause of the reported event, not the cook device.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.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 LIBERATOR BEACON TIP LOCKING STYLET
• Common Device Name: DRB STYLET, CATHETER
• 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: kimberly platt ; 1186 montgomery lane; vandergrift, PA 15690-6065 ; 7248458621
• MDR Report Key: 24349666
• Report Number: 2522007-2026-00003
• Device Sequence Number: 5066166
• Product Code: DRB
• UDI-Device Identifier: 10827002265506
• UDI-Public: (01)10827002265506(17)280531(10)N217969
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K170298
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: G26550
• Device Catalogue Number: LR-OFA01
• Device Lot Number: N217969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 16F LASER
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown