MAUDE Adverse Event Report: VENCLOSE, INC. VENCLOSE EVSRF CATHETER; VENOUS CATHETER

Catalog Number VCOUS6F60

Device Problems Overheating of Device (1437); Material Deformation (2976)

Patient Problem Burn(s) (1757)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

H10: h10: the catalog number identified in section d4 has not been cleared in the us but is similar to the venclose evsrf catheter that are cleared in the us.The pro code and 510 k number for the venclose evsrf catheter are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 10/2025).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device pending return.

Event Description

It was reported that during a rf ablation procedure, the insulation in the distal third of the catheter was allegedly not intact.It was further reported that the healthcare professional allegedly experienced burn wound.Reportedly, the burn wound was still clearly visible days later and the catheter also alleged had a kink when the catheter was pulled out of the vein.The current status of patient is unknown.

• Brand Name: VENCLOSE EVSRF CATHETER
• Type of Device: VENOUS CATHETER
• Manufacturer (Section D): VENCLOSE, INC.; 2750 n. first street; 2nd floor, #221; san jose CA 95131
• Manufacturer (Section G): VENCLOSE, INC.; 2750 n. first street; 2nd floor, #221; san jose CA 95131
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18998989
• MDR Text Key: 338874937
• Report Number: 3011879048-2024-00006
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160754
• 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
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VCOUS6F60
• Device Lot Number: 73319896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• 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
• Patient Outcome(s): Required Intervention