MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET; DQX WIRE, GUIDE, CATHETER

Model Number	G26550
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicated the information is unknown, unchanged, or unavailable.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.G5 ¿ pma/510(k): k170298.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
As initially reported to customer relations: a 74-year-old male patient underwent a lead extraction/heart procedure in which the lead extraction liberator beacon tip locking stylet, g26550, was used.The electrode is debrided from the pacemaker bag, the stylet wires are introduced to release fixation and verify patency, the connector is cut and the liberator guide is introduced, making sure that it reaches the distal tip of the electrode by means of fluoroscopy.Upon reaching the most distal part of the electrode, the spikes are released from the guide.Due to the traction inferred at the moment of releasing, it is separated from the extensor of the same, bringing the external lumen of the guide, leaving the inner part of the liberator inside the cable and the patient.
Event or Problem Description
As initially reported to customer relations: a 74-year-old male patient underwent a lead extraction/heart procedure in which the lead extraction liberator beacon tip locking stylet, g26550, was used.The electrode is debrided from the pacemaker bag, the stylet wires are introduced to release fixation and verify patency, the connector is cut and the liberator guide is introduced, making sure that it reaches the distal tip of the electrode by means of fluoroscopy.Upon reaching the most distal part of the electrode, the spikes are released from the guide.Due to the traction inferred at the moment of releasing, it is separated from the extensor of the same, bringing the external lumen of the guide, leaving the inner part of the liberator inside the cable and the patient.
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 and the lot of the device was unknown, however the device was returned and lot was known.D4 - model: g26550.E3 - occupation: sub director.G5 ¿ pma/510(k): k170298.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
As initially reported to customer relations: a 74-year-old male patient underwent a lead extraction/ heart procedure in which the lead extraction liberator beacon tip locking stylet, (b)(6), was used.The electrode is debrided from the pacemaker bag, the stylet wires are introduced to release fixation and verify patency, the connector is cut and the liberator guide is introduced, making sure that it reaches the distal tip of the electrode by means of fluoroscopy.Upon reaching the most distal part of the electrode, the spikes are released from the guide.Due to the traction inferred at the moment of releasing, it is separated from the extensor of the same, bringing the external lumen of the guide, leaving the inner part of the liberator inside the cable and the patient.
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 and the lot of the device was unknown, however the device was returned and the lot was known.E3 - occupation: sub director.G5 ¿ pma/510(k): k170298.One liberator that was in multiple pieces was returned on this complaint.There was no latch pin or activation piece returned on this complaint, but there was a lead that was returned on this complaint as well.The customer complaint/event that was entered and reported within trackwise: "inner part of the liberator inside the cable and the patient." the quality assurance department performed an investigation / evaluation on the returned pieces/device.Visually the device appeared to have been returned cleaned/decontaminated prior to returning.The device was in a style that the handle was wrapped up.Visually the wire was broken after the handle solder.This may have been from excessive pulling and appears to have tensile failure that may have caused the break.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 the complaint summary tab of 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.

• Brand Name: LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer (Section G): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: timothy vogel ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 19980324
• Report Number: 2522007-2024-00026
• Device Sequence Number: 2846787
• Product Code: DQX
• UDI-Device Identifier: 10827002265506
• UDI-Public: (01)10827002265506(17)270331(10)N203954
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2024

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: N203954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 08/27/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/09/2024; 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Male