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

Catalog Number VS-402

Device Problem Partial Blockage (1065)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician intended to use venaseal and transducer compression for the treatment of the great saphenous vein (gsv).The ifu was followed.A guidewire was not used for insertion of the catheter.It is reported the glue catheter successfully dispensed 2 injections of glue but following this it was noted that blood backed up into the catheter tip and sealed it.No more glue was dispensed.The catheter was removed from the patient and the tip was cut off to see if this would rectify the problem, but it sealed off and was unusable.It is reported there were no challenges or deviations related to the location of the catheter tip prior to initial delivery of adhesive.The physician used foam to complete the vein closure.After the procedure the patient wore compression stockings.

Manufacturer Narrative

The venaseal kit was returned for evaluation and included the venaseal gun, 2 blunt tip needles, 2 syringes, vial of adhesive (approx.33% full), pair of gloves, blue introducer, dilator, glue catheter, and j-wire.The introducer, dilator, and catheter were all loaded in individual protective tubing.Traces of dried adhesive was observed through out all of the components.The j-wire showed dried blood approximately 30cm rom the curved tip.One of the returned syringes was loaded with approximately 0.5ml of adhesive, the other syringe was empty.The effective length of the catheter was approximately 92.5cm.The distal tip showed a flat edge consistence with being subjected to being cut with a sharp instrument and adhesive was observed within the inner diameter of the distal tip.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,gw
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,gw
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7344366
• MDR Text Key: 102574310
• Report Number: 9612164-2018-00520
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 20643169986262
• UDI-Public: 20643169986262
• 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: 05/03/2018

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: 01/31/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 49993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/16/2018
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• 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