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

Catalog Number VS-402

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 03/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician was intending to use venaseal kit to treat the right great saphenous vein (gsv).The ifu was followed and the lumen was flushed prior to use.A guidewire was used for insertion of the catheter.It was reported that the sheath got stuck inside the vein.The patient experienced pain during the attempted removal of the catheter.The patient also complained of chest pain in the left side.The procedure was abandoned as the patient had to go to the emergency room.The 0.035 j wire was advanced up the gsv to the sfj.The blue sheath which was wiped down by wet 4x4 and dilator went over the wire and advanced to the proximal thigh.The blue sheath wouldn¿t advance any further.Physician decided to just treat from that point on.Gw and dilator was removed.Physician pulled the blue sheath back but the physician had difficulties pulling the catheter back.Every time he pulled, the patient complained of pain on her entire leg.Physician applied warm compress and nitropaste over the access and length of gsv and waited 10 min, but vein was still spasmed, and physician continued having difficulties pulling the catheter back.Patient states she was having chest pain.Physician gave patient nitro pill, checked ekg and blood pressure.Physician decided to apply tumescent at the access site to numb the vein more.When the patient complained more pain, physicians then decided to just pull out the catheter, patient didn¿t feel much at that time.Patient complained of pain 8/10.After taking 2 nitro pills, patient continued to have left side chest pain and radiated to her back.Physician decided to call the ambulance to send her to the emergency room.

Manufacturer Narrative

The patient complained of mid-sternal chest pain with radiation to the back, neck and side of the chest.The patient reported experiencing pain every other night, with nausea and shortness of breath with chest pain.After taking 2 nitro pills, patient continued to have left side chest pain, radiating to her back.The patient is said to be feeling well.Evaluation summary: the returned venaseal kit included a blue introducer, a venaseal catheter connected to a 3ml syringe filled with 1ml of adhesive and the dispensing gun.Other accessories returned included an empty 10 ml syringe, an unknown blue sheath with a 0.018" guidewire loaded.These accessories are not included in the venaseal kit that medtronic supplies.Each returned component was individually inspected.The guidewire loaded in the short blue introducer was approximately 45cm long.Traces of dried blood were observed on the coiled tip (10cm segment at the distal end).The short blue introducer was approximately 16 cm long.No damages were observed.The guidewire was able to be removed with resistance due to dried blood on the od of the wire.The 10ml syringe was inspected and approximately 1ml of clear fluid (likely saline/water) was observed loaded in the barrel of the syringe.No damages were noted.The dispensing gun showed dried blood on the outside housing.No damages were noted.The blue introducer was inspected and traces of dried blood within the inner diameter of the distal rim were noted.No damages were observed.The venaseal catheter with the 3ml syringe connected to hub showed adhesive within the lumen of the catheter shaft.The distal tip of the catheter showed adhesive dried to the distal tip.There was approximately 1.5ml of adhesive within the syringe.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: 8439672
• MDR Text Key: 139437191
• Report Number: 9612164-2019-00973
• 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
• Report Date: 07/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 53199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 07/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 84