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 Code	Foreign Body In Patient (2687)
Date of Event	11/03/2025
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.E1 - title: (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
2x lr-ofa01 devices inserted into right atrium (ra)1 & right ventricle (rv)1 left sided pacing leads due for extraction.3rd liberator (lot number n215551) inserted and activated within targeted rv2 lead.Onetie applied.Traction applied and no retraction noted.Activated correctly with guided instruction from merit support personnel).Ra1 lead, liberator pulled back leaving active filament portion of device still inside of targeted lead.Rv1 lead, activated and fixed with onetie proximal compression coil.When direct traction applied, liberator began to retract within the lead, pulled back to subclavian region of body.Device appeared intact within the lead, beacon tip marker visible within subclavian region of lead.

• 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: curtis gaul ; 1186 montgomery lane; vandergrift, PA 15690-6065 ; 7248458621
• MDR Report Key: 23693263
• Report Number: 2522007-2025-00031
• Device Sequence Number: 21130456
• Product Code: DRB
• UDI-Device Identifier: 10827002265506
• UDI-Public: (01)10827002265506(17)280331(10)N215242
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170298
• 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
• Report Date (Section B): 12/02/2025

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: G26550
• Device Catalogue Number: LR-OFA01
• Device Lot Number: N215242
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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
• Patient Sex: Unknown