MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION

Model Number	G23746
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Cardiac Perforation (2513)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicated the information is unknown, unchanged, or unavailable.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
Extraction.Hole in atrial appendage.Chest opened.2 stitches.Patient is fine.Cause of hole passive lead.Although the whole extraction kit was used, the passive lead caused the hole.The passive leads caused a hole in the atrial appendage.No equipment was at fault.Patient is fine and recovering.
Additional Manufacturer Narrative
The device was not returned for the complaint; therefore, a physical investigation could not be performed, and the customer's complaint could not be confirmed, other than by the customer's testimony.The complaint/event that was entered and reported within trackwise: "during extraction passive leads caused small hole in the arterial appendage." 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.G5 ¿ pma/510(k): k141148 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
Extraction.Hole in atrial appendage.Chest opened.2 stitches.Patient is fine.Cause of hole passive lead.Although the whole extraction kit was used, the passive lead caused the hole.The passive leads caused a hole in the atrial appendage.No equipment was at fault.Patient is fine and recovering.
Additional Manufacturer Narrative
Corrected data (b)(6) 2024 ahe per the following d4 - udi: the udi information per 21cfr 803.52(c)(4) and 21 cfr 803.50(b) that is required has been added/updated to this report: d4 model: g23746.The device was not returned for the complaint; therefore, a physical investigation could not be performed, and the customer's complaint could not be confirmed, other than by the customer's testimony.The complaint/event that was entered and reported within trackwise: "during extraction passive leads caused small hole in the arterial appendage." 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.G5 ¿ pma/510(k): k141148.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
Extraction.Hole in atrial appendage.Chest opened.2 stitches.Patient is fine.Cause of hole passive lead.Although the whole extraction kit was used, the passive lead caused the hole.The passive leads caused a hole in the atrial appendage.No equipment was at fault.Patient is fine and recovering.

• Brand Name: LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION
• 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: 18366588
• Report Number: 2522007-2023-00026
• Device Sequence Number: 7697098
• Product Code: DRE
• UDI-Device Identifier: 10827002237466
• UDI-Public: (01)10827002237466(17)240331(10)N178746
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2024

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 Expiration Date: 03/31/2024
• Device Model Number: G23746
• Device Catalogue Number: LR-EVN-11.0-RL
• Device Lot Number: N178746
• Was Device Available for Evaluation?: No
• 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: Not provided; Not provided
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 04/05/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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: Female