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

Model Number VC-10A2.5-6F-60

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

Patient Problem Phlebitis (2004)

Event Date 06/09/2021

Event Type  Injury  

Event Description

It was reported that some time following an rf ablation procedure, the patient experienced extreme leg pain.Reportedly, after three post op visits with the procedural physician, with no resolution to the pain, the patient went to another hospital for a second opinion and was allegedly prescribed gabapentin for chronic pain syndrome.There was no report of any device malfunction.

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported that during and after a rf ablation procedure, the patient allegedly experienced extreme leg pain.After three post op visits with the procedural physician, with no resolution to the pain, the patient went to another hospital for a second opinion and was allegedly prescribed gabapentin for chronic pain syndrome.There was no report of any device malfunction.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive for the alleged adverse event without identified device or use problem as no objective evidence has been provided to confirm any alleged deficiency with the catheter.A definitive root cause for the alleged adverse event without identified device or use 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.

• 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: 16611949
• MDR Text Key: 311959355
• Report Number: 3011879048-2023-00006
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00858254006008
• UDI-Public: 00858254006008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VC-10A2.5-6F-60
• Device Catalogue Number: VC10A256F60
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2023
• 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
• Patient Outcome(s): Other
• Patient Sex: Female