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

Model Number VC-10A2.5-6F-100

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2023

Event Type  malfunction  

Event Description

It was reported that during an endovenous ablation treatment, the catheter allegedly burned the introducer sheath outside of the treatment segment.No patient injury was reported.

Manufacturer Narrative

The lot number of the device was provided.The device history records are currently under review.The device has not been returned for evaluation.The investigation is currently underway. .

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation; however, two evsrf 100cm catheter pictures were received for photo review.The first photo shows the catheter, shaft, and unknown sheath assembly.The white sheath appears burned and separated into small pieces and still attached to the coil.The other photo shows a close up of the sheath burned and separated.Upon visual inspection of the picture, it is confirmed there was a temperature problem that caused the sheath to burn to the coil.Since the actual sample was not returned, no functional testing was performed.A definitive root cause for the temperature problem could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11:section a through f - the information provided by bd represents all of 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.

Event Description

It was reported that during an endovenous ablation treatment, the catheter allegedly burned the introducer sheath outside of the treatment segment.No patient injury was reported.

• 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: 16602839
• MDR Text Key: 312060788
• Report Number: 3011879048-2023-00005
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00858254006015
• UDI-Public: (01)00858254006015
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VC-10A2.5-6F-100
• Device Catalogue Number: VC10A256F100EU
• Device Lot Number: 66030181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• 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