MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION BYRD POLYPROPYLENE EXTRA LONG DILATOR SHEATH SET; GCC DILATOR, CATHETER

Catalog Number LR-PPLBES-11.5-XL

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

Patient Problem Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 02/29/2024

Event Type  Injury  

Event Description

Lead removal was performed.The located site was right ventricle and lr-pplbes-11.5-xl, lr-evn-11.0-rl, lr-evn-13.0-rl, lr-tss-13.0 were approached from the left subclavian vein.During the procedure, the sheath did not advance at all beyond the tricuspid valve area.(the sheath didn't advanced in all the devices they used.) since the patient was infected, the sheath had to be removed anyway, and the lead was somehow removed.After discussion with the cardiovascular surgeon, it was decided that there was no need to open the chest and we would wait and see what would happen.The operation was performed at 9:00 am when he entered the room and left 3:00 pm.After the lead was removed and the patient left the room, the patient's condition deteriorated and an open chest was performed.Information on the patient's condition after that has not yet been obtained.

Manufacturer Narrative

Event is not reportable under cmdr sec.59.Brazil=yes.Event is reportable under fda 21 cfr part 803 as there was a serious injury while the device was being used.13mar2024 ahe.

• Brand Name: LEAD EXTRACTION BYRD POLYPROPYLENE EXTRA LONG DILATOR SHEATH SET
• Type of Device: GCC DILATOR, CATHETER
• 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: 18897082
• MDR Text Key: 337586266
• Report Number: 2522007-2024-00011
• Device Sequence Number: 1
• Product Code: GCC
• Combination Product (y/n): N
• PMA/PMN Number: K893480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LR-PPLBES-11.5-XL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: LR-EVN-11.0-RL.; LR-EVN-13.0-RL.; LR-TSS-13.0.
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male