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

Model Number	G23748
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/07/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product code: dre.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.
Event or Problem Description
It was reported that a patient underwent a lead extraction procedure (b)(6) 2021.Shortly after starting procedure, the user noted more bleeding than usual, but believed this was not a major problem at that time.After both the right ventricular and right atrium leads were removed, a blood transfusion was performed.In attempt to stop bleeding, a sheath (not for lead removal) was inserted into the puncture site without success.The bleeding site was believed to be somewhere in the subclavian vein, not the puncture site; therefore a wire guide was employed from the right femoral to the subclavian vein.The balloon was then inflated in an effort to try to stop the bleeding, but failed.The user called plastic and vascular surgeons which were able to stop the bleeding.It was estimated that the damage to the subclavian vein was less than 10cm from the puncture site.Additional information received has indicated that the patient died due to sepsis.

• Brand Name: LEAD EXTRACTION EVOLUTION SHORTIE 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
• Manufacturer (Section G): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 12028466
• Report Number: 2522007-2021-00020
• Device Sequence Number: 17334613
• Product Code: DRE
• UDI-Device Identifier: 00827002237483
• UDI-Public: (01)00827002237483(17)230731(10)N173496
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (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): 02/25/2022

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: 07/31/2023
• Device Model Number: G23748
• Device Catalogue Number: LR-EVN-SH-9.0-RL
• Device Lot Number: N173496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• 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: Death
• Patient Sex: Male