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

Catalog Number SP-101

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use venaseal to treat one segment of the great saphaneous vein (gsv).The lumen was flushed prior to use.The ifu was followed and a guidewire was used.Local anaesthesia and transducer compression was used and the vein successfully closed.A vein flow needle was used to puncture the skin and a stitch incision was made.It was reported that while accessing the vein, the blue sheath fanned out but that this was only recognised after the procedure.Another product was used for treating the patient¿s second leg.The patient felt some pain during positioning of the sheath to the sfj.No patient injury was reported.

Manufacturer Narrative

Device evaluation: the component blue introducer was returned loosely in a zip bag.No other components from the venaseal kit were received for evaluation.The component was removed from the packaging for further inspection.Visual inspection of blue introducer revealed the distal was damaged.There is evidence of a tear of the distal tip image review: one image was received from the customer.Per the image, a damage was observed on the distal tip of the blue introducer.A dilator and guidewire were inserted into the blue introducer.The reported event was confirmed based on the image received.Per the reported event, the blue sheath fanned out but that this was only recognized after the procedure.It is unknown what may have caused the reported damage.The device was returned to analysis lab to perform additional analysis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8361226
• MDR Text Key: 136849488
• Report Number: 9612164-2019-00604
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: SP-101
• Device Lot Number: 53077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2018
• 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 Age: 54 YR