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

Model Number VS-402

Device Problems Device Difficult to Setup or Prepare (1487); Physical Resistance/Sticking (4012)

Patient Problem Blood Loss (2597)

Event Date 01/31/2020

Event Type  Injury  

Manufacturer Narrative

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).Ifu was followed.The physician flushed the blue venaseal introducer and left the syringe attached.During the prep and priming of the venaseal delivery catheter the physician noted the blue venaseal introducer would not flush again.The elapsed time between when the blue introducer was flushed to when it would not flush was about 1-2 minutes.The primed delivery catheter was inserted into the blue venaseal introducer with noted resistance.A clot was identified in the shape of the blue introducer along the proximal gsv through the saphenofemoral junction (sfj) into the common femoral vein.The venaseal delivery catheter with the attached blue introducer were removed from the patient.The 7 fr.Sheath was removed from the patient.Pressure was held to achieve haemostasis.A dry sterile dressing was applied.When the patient started to walk around the bleeding continued, pressure was applied, and haemostasis was achieved again.The initial dressing was saturated with blood and replaced with another dry sterile dressing.The procedure was aborted, and the physician prescribed eliquis to the patient for a 7-day course.The patient is scheduled to return for follow up next week.It will be determined at follow up if the clot has resolved to reschedule the patient for the venaseal procedure.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis: the venaseal device was returned within a saftpak biohazard pouch and within a clear biohazard bag.Blood residue was observed on all the returned components.The catheter tip was occluded with dried adhesive.Blood residue was observed on the entire catheter shaft.No physical damage was noted on the catheter.The blue introducer was occluded with blood residue within its lumen.Due to the occlusion of the introducer, a known good catheter from analysis lab cannot be inserted within the introducer.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the procedure was aborted during an attempt to treat the left great saphenous vein (gsv) with venaseal.No adhesive was administered to the patient.Patient had a follow up consultation approximately 4 weeks after the procedure.There is no ultrasound evidence of the suspicious area of the clot.The gsv in the left lower extremity of the leg has occluded, but the upper vessel remains incompetent and open.No presence of edema.There is still some heaviness in the left leg, but this is not debilitating.There is no walking related complaints compatible with claudication.Patient is in good health with no major medical or surgical problems.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: 9659116
• MDR Text Key: 177539687
• Report Number: 9612164-2020-00520
• Device Sequence Number: 1
• Product Code: PJQ
• 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,Followup,Followup,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 57181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 02/24/2020; 03/10/2020; 03/17/2020
• Supplement Dates FDA Received: 02/26/2020; 03/12/2020; 03/19/2020
• Date Device Manufactured: 09/25/2019
• 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
• Patient Age: 66 YR
• Patient Weight: 100