MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Model Number VS-402

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the venaseal components were returned within its shelf box.Components include: dispenser gun, blue introducer, a syringe, 0.035in guidewire.An non medtronic ancillary device(needle), was returned with the venaseal components.Per the reported event, physician intended to use a venaseal kit during treatment of the patient¿s great saphenous vein (gsv).The physician reported that a needle was used to gain access into the vein and a 0.035 guidewire was passed through the needles, but the needle was unable to be removed back over the guidewire.The 0.035in guidewire was returned detached.A portion of the detached guidewire was observed on the non medtronic device(needle).Visual inspection of the detached portion of the guidewire revealed torsional stretching and twisting.The guidewire distal end and j -ends were returned to lab.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a venaseal kit during treatment of the patient¿s great saphenous vein (gsv).The physician reported that a needle was used to gain access into the vein and a 0.035 guidewire was passed through the needles, but the needle was unable to be removed back over the guidewire.The device was safely removed from the patient and there was no vessel damage reported.A new venaseal kit was opened and used without issue to carry out treatment.No patient injury reported.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10829244
• MDR Text Key: 215922822
• Report Number: 9612164-2020-04398
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 00643169986268
• UDI-Public: 00643169986268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 58612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2020
• 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