MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION; DXE CATHETER, EMBOLECTOMY

Catalog Number	LR-NES001
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G5 ¿ pma/510(k): k141148.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
The needle eye snare broke in the patient.Cc form, the nes system was used according to the instruction of use with the seldinger technique.After the dr.Inserted the nes system via the outer sheath upto the right ventricle they saw on the x-ray that there was a sharp end.The nes system was removed a replaced by a new system.
Additional Manufacturer Narrative
G5: pma/510(k): k141148.One device (lr-nes001 n189960) was returned on this complaint.The quality assurance department investigated the returned device visually and functionally.Visually the device had blood present throughout the device.The snare was broken at the point where all four wires come together.There was some discoloration at the broken end of the snare where the wire did not have the shiny appearance anymore.There were a few "smashes" within the tubing itself.Functionally, the device did not move when the black knob was pulled back and felt as if the inner wires were trying to move but were restricted.The investigation did indeed confirm the customer's complaint that the device was broken and by customer's testimony that it occurred in the patient.The device history record (dhr) was reviewed, including manufacturing and quality control records and there are no signs to indicate that the device was not manufactured to current specifications.This complaint mode is being monitored, tracked and trended per the cvi post market surveillance and complaint handling processes.A risk assessment will be performed and documented in the complaint summary tab in 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
The needle eye snare (nes) broke in the patient.Cc form: the nes system was used according to the instruction of use with the seldinger technique.After the dr.Inserted the nes system via the outer sheath up to the right ventricle they saw on the x-ray that there was a sharp end.The nes system was removed a replaced by a new system.

• Brand Name: LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
• Common Device Name: DXE CATHETER, EMBOLECTOMY
• 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: 17434504
• Report Number: 2522007-2023-00009
• Device Sequence Number: 8884934
• Product Code: DXE
• UDI-Device Identifier: 10827002265179
• UDI-Public: (01)10827002265179(17)250731(10)N189960
• 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
• Report Date (Section B): 10/16/2023

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 Expiration Date: 07/31/2025
• Device Catalogue Number: LR-NES001
• Device Lot Number: N189960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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: 65 YR
• Patient Sex: Male