MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH

Model Number	G25084
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per sales representative on 26jan2022; the metal stabilizing tip broke off in the patient in the upper left chest.They were able to retrieve it with no harm to the patient but the sales representative has not yet confirmed the method used to retrieve it.
Additional Manufacturer Narrative
Product code: dre.Pma/510(k): k141148.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
D2b: product code: dre.G5: pma/510(k): k141148.No device was returned on this complaint, therefore a physical investigation could not be performed and the complaint could not be confirmed.The complaint/event entered within trackwise: "the metal stabilizing tip broke off in the patient." per complaint information: "the metal stabilizing tip broke off in the patient in the upper left chest.They were able to retrieve it with no harm to the patient but the rep has not yet confirmed the method used to retrieve it." the device history record (dhr) was reviewed, including manufacturing and quality controls and there were no signs to indicate that nonconforming product was manufactured and shipped to the field.This complaint type will continue to be monitored, tracked and trended per cvi's complaint handling and post market surveillance 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.

• Brand Name: LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH
• 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: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 13581259
• Report Number: 2522007-2022-00006
• Device Sequence Number: 19972298
• Product Code: DRE
• UDI-Device Identifier: 00827002250840
• UDI-Public: (01)00827002250840(17)221031(10)N167924
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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: 10/31/2022
• Device Model Number: G25084
• Device Catalogue Number: LR-TSS-13.0
• Device Lot Number: N167924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• 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: Required Intervention
• Patient Sex: Unknown