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 Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Lead locking devices and laser sheath were used, then 13fr evolution was used.Physician noticed blood pressure dropping.
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
Lead locking devices and laser sheath were used, then 13fr evolution was used.Physician noticed blood pressure dropping.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable g4 ¿ pma/510(k): (b)(6).One lr-evn-13.0-rl device was returned with an outer sheath on the device.Both devices were heavily covered in a wet blood.The customer complaint/event that was entered and reported into trackwise: "patient's blood pressure dropped." the quality assurance department investigated the returned used device.Visually the device was heavily covered in a very wet blood along with an outer sheath.The device itself along with sheath had a mild bend / curvature to it, however this may have been due to the packaging it was returned in.The device was functionally inspected.Visually, the device was inspected under a microscope.Visually the evn device's tip showed no signs of any abnormalities on it.The device functions as intended.Visually no other deformities/abnormalities were noted with this device.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.

• 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: 17116365
• Report Number: 2522007-2023-00003
• Device Sequence Number: 12522349
• Product Code: DRE
• UDI-Device Identifier: 10827002237473
• UDI-Public: (01)10827002237473(17)251031(10)N191752
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023

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: 10/31/2025
• Device Model Number: G23747
• Device Catalogue Number: LR-EVN-13.0-RL
• Device Lot Number: N191752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• 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: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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: LASER SHEATH; LASER SHEATH; LEAD LOCKING DEVICES; LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Female