MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION ONE-TIE¿ COMPRESSION COIL

Catalog Number	LR-OTE-N
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common name: instruments, surgical, cardiovascular.Product code: dws.Concomitant devices: cook liberator beacon tip locking stylet, evolution shortie 9 fr, and byrd dilator sheath 8.5fr, 10fr, 11.5fr.Pma/510(k): class i (exempt).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 the physician made lead control in the right atrial lead with liberator, one-tie, and evolution shortie 9 french.Access for procedure was gained from the left subclavian vein.After the tip of the lead was removed, lead extraction was attempted using a snare (other manufacturer) with a femoral approach.After grasping the tip of the lead with the snare, the physician confirmed that the lead coming out of the upper limb and the portion held by the snare were pull-through, without adhesions in the middle.However, the patient's side (distal end of the one-tie) should have been cut off, but the surgeon's side (proximal end of the one-tie) was cut off instead.As a result, the lead with the one-tie attached was pulled into the femoral region by the snare.Another physician who was at the side of the lower extremity inserted a 16fr sheath from the inguinal region.The 16fr sheath was removed and the thickened lead with attached one-tie was unable to pass through the puncture site and became stuck.The physician tried unsuccessfully to introduce the one-tie into cook's byrd dilator sheath via the inguinal lead, therefore the transvenous approach was abandoned.A vascular surgeon ultimately had to make an incision and remove the lead where the one-tie was attached.

• Brand Name: LEAD EXTRACTION ONE-TIE¿ COMPRESSION COIL
• 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: 12247021
• Report Number: 2522007-2021-00023
• Device Sequence Number: 17393883
• Product Code: DWS
• UDI-Device Identifier: 00827002319295
• UDI-Public: (01)00827002319295(17)230630(10)N172796
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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: 06/30/2023
• Device Catalogue Number: LR-OTE-N
• Device Lot Number: N172796
• 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: 07/05/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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: Required Intervention
• Patient Sex: Male