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

Model Number	G23746
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	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product code: dre.Concomitant medical devices: liberator beacon tip locking stylet (lr-ofa0), evolution shortie rl controlled-rotation dilator sheath set 11fr.(lr-evn-sh-11.0-rl).Pma/510(k): k141148.(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.
Event or Problem Description
It was reported to customer relations that during a lead extraction procedure,"the 11fr cook evolution tool was advanced, the lead was removed and the patient had a hypotensive episode." "pericardial centesis was done, cpr begun, and a pericardial window done.".
Additional Manufacturer Narrative
Additional information: h6- ec method code desc - 1: device not returned (4114).H6- ec method code desc - 2: historical data analysis (4109).H6- ec results code desc - 1: changed to no findings available (3221).H6- ec conclusions code desc - 1: changed to known inherent risk of device (22).Investigation-evaluation: the lr-evn-11.0-rl was not returned to cook vandergrift inc.For investigation.The customer complaint/event that was reported per the trackwise entry: "as reported to customer relations: "the 11fr cook evolution tool was advanced, lead was removed and patient.Had hypotensive episode.Pericardial centesis was done, cpr begun, pericardial window done." the lead extraction evolution rl controlled-rotation dilator sheath set was not returned, the quality engineering and engineering departments could not perform a physical investigation.The ifu fm-292was reviewed, and one of the warnings listed is "do not apply weighted traction to an inserted locking stylet as myocardial avulsion, hypotension, or venous wall tearing may result." also included in the ifu are the potential adverse events, which includes "acute hypotension." since the device was not returned it is inconclusive if the cause was due to the events mentioned in the ifu.Without the device to physically investigate a defect of the device or the manufacturing process is inconclusive.This occurrence will continue to be monitored per the cvi complaint handling and post market surveillance processes.The device history record (dhr), including quality control and manufacturing records, were reviewed.All process steps were complete and signed off by trained personal.A risk assessment was performed per qera 200724.1 and documented in 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.
Event or Problem Description
As reported to customer relations: "the 11fr cook evolution tool was advanced, lead was removed and patient.Had hypotensive episode.Pericardial centesis was done, cpr begun, pericardial window done.".

• Brand Name: LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Common Device Name: VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 8451500
• Report Number: 2522007-2019-00001
• Device Sequence Number: 429155
• Product Code: DRE
• UDI-Device Identifier: 10827002237466
• UDI-Public: (01)10827002237466(17)211231(10)N161262
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 12/31/2021
• Device Model Number: G23746
• Device Catalogue Number: LR-EVN-11.0-RL
• Device Lot Number: N161262
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 97