MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION; DXE CATHETER, EMBOLECTOMY

Catalog Number LR-NES001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Product code: dxe.Concomitant medical products: phillips glide light 14fr.And 16fr.Lasers and sheath, cook curved femoral sheath (lr-crvfem001), cook curve femoral introducer sheath set (lr-css16).Pma/510(k): k961992.(b)(4).

Event Description

It was reported that after removing the lead in the right atrium, during a lead extraction procedure, the physician started to detach the lead in the right ventricle from a superior approach.However, the adhesions near the tip of the lead were so strong that the glide light 14fr (laser sheath/philips), which was being approached from the subclavian vein, got stuck near the lead tip and would not move.The physician tried to remove the stuck lead by changing to an femoral approach and pulling it from below the vein of the inguinal region, using the reported lead extraction needle's eye femoral snare (lr-nes001), but they were unable to the lead.The physician then used a cook curve femoral introducer sheath set (lr-css16) and a cook curved femoral sheath (lr-crvfem001) together.The physician managed to grab the right ventricle lead using the needle's eye femoral snare (lr-nes-001) and pull it downward.They were then able to retrieve the stuck philips glide light 14fr.The physician changed from a philips glide light 14fr to a philips glide light 16fr.With the philips glide light 16fr, the physician attempted to detach the adhesion, but there was a "long adhesion or tissue" on the lead tip, which the philips glide light 16fr could not burn off.The laser was irradiated around 10 times at the tip of the lead.It was confirmed by fluoroscopy that the tip of the lead was in the sheath of the glide light, but the physician was unable to pull the lead out; he assumed that there was tissue attached to the lead tip.They grabbing the tissue attached to the lead tip using the reported needle's eye femoral snare (lr-nes001) and simultaneously irradiated the tissue with the laser at the superior approach.The lead tip came out however, the physician observed the patient after the lead was removed, anticipating a possibility of cardiac tamponade.They confirmed pericardial effusion.Soon after that, the physician performed pericardiocentesis and drainage of the pericardial effusion.However, patient¿s blood pressure didn't improve, necessitating thoracotomy.Consequently, a laceration of the right ventricular apex was found, and the bleeding site was treated.The patient has reportedly recovered from this event.

• Brand Name: LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
• Type of Device: DXE CATHETER, EMBOLECTOMY
• 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: 11361057
• MDR Text Key: 242812235
• Report Number: 2522007-2021-00010
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 10827002265179
• UDI-Public: (01)10827002265179(17)220331(10)N163561
• Combination Product (y/n): N
• PMA/PMN Number: K961992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: LR-NES001
• Device Lot Number: N163561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female