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

Model Number	G23747
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During removal of a right ventricle (rv) lead implanted in 1995, blood pressure dropped after the tip of the lead was detached and removed with evolution 13fr.The blood pressure, which was 85/44 at the beginning of the procedure, dropped to 35/24 in a few seconds.After removal of the rv lead, transesophageal echocardiography was performed to check for cardiac tamponade, which showed a decrease in blood pressure along with pericardial effusion.The patient was diagnosed with cardiac tamponade.Cardiovascular physician immediately initiated cardiac massage, connected to percutaneous cardiopulmonary support (pcps), performed median sternotomy, and repair procedure was performed.The patient returned to intensive care unit (icu).
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable, g4 ¿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.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
During removal of a right ventricle (rv) lead implanted in 1995, blood pressure dropped after the tip of the lead was detached and removed with evolution 13fr.The blood pressure, which was 85/44 at the beginning of the procedure, dropped to 35/24 in a few seconds.After removal of the rv lead, transesophageal echocardiography was performed to check for cardiac tamponade, which showed a decrease in blood pressure along with pericardial effusion.The patient was diagnosed with cardiac tamponade.Cardiovascular physician immediately initiated cardiac massage, connected to percutaneous cardiopulmonary support (pcps), performed median sternotomy, and repair procedure was performed.The patient returned to intensive care unit (icu).
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable, g4 ¿pma/510(k): (b)(4).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: "cardiac tamponade of the right ventricle." per complaint: "during removal of a right ventricle (rv) lead implanted in 1995, blood pressure dropped after the tip of the lead was detached and removed with evolution 13fr.The blood pressure, which was 85/44 at the beginning of the procedure, dropped to 35/24 in a few seconds.After removal of the rv lead, transesophageal echocardiography was performed to check for cardiac tamponade, which showed a decrease in blood pressure along with pericardial effusion.The patient was diagnosed with cardiac tamponade.Cardiovascular physician immediately initiated cardiac massage, connected to percutaneous cardiopulmonary support (pcps), performed median sternotomy, and repair procedure was performed.The patient returned to intensive care unit (icu).", " i do not think it was a technical problem or a problem with the device.As the doctors said, the most important factor was that the lead tip had been placed in a location where complications were likely to occur." 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 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: 17116649
• Report Number: 2522007-2023-00004
• Device Sequence Number: 7200401
• Product Code: DRE
• UDI-Device Identifier: 10827002237473
• UDI-Public: (01)10827002237473(17)250331(10)N187478
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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: 03/31/2025
• Device Model Number: G23747
• Device Catalogue Number: LR-EVN-13.0-RL
• Device Lot Number: N187478
• 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
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LR-LED01; LR-LED01; PHILIPS / LEAD LOCKING DEVICE (B)(6); PHILIPS / LEAD LOCKING DEVICE (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male