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

Catalog Number LR-EVN-9.0-RL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.G5 ¿ pma/510(k): (b)(4).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 Description

Adverse event adverse event hole in atrial appendage, chest opened and hole repaired.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.The device was not returned for the complaint; therefore, a physical investigation could not be performed, and the customer's complaint is acknowledged, but could not be confirmed, other than by the customer's testimony.The complaint/event that was entered and reported within trackwise: "adverse event hole in atrial appendage, chest opened and hole repaired." per complaint entry: "the patient is fine.A section of the device did not remain inside the patient¿s body.The patient did require additional procedures due to this occurrence.It appears the actual removal of the lead from heart wall appeared to cause the problem.Chest opened by surgeon, repaired the hole.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Bleeding caused by the hole.Repaired by cardiac surgeon.Patient is recovering well.2 liberator locking stylets and 1 evolution were used." 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.G5 ¿ pma/510(k):(b)(6).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 Description

Adverse event adverse event hole in atrial appendage, chest opened and hole repaired.

• Brand Name: LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Type of Device: 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: 18907323
• MDR Text Key: 337730064
• Report Number: 2522007-2024-00012
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 10827002237374
• UDI-Public: (01)10827002237374(17)251231(10)N193183
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: LR-EVN-9.0-RL
• Device Lot Number: N193183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male