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

Catalog Number SP-101

Device Problem Material Puncture/Hole (1504)

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

Event Date 10/10/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician was attempting to use a venaseal to treat the short saphenous vein (ssv).The ifu was followed and the device was prepped without issue.A guidewire was used for catheter insertion.It was reported that the patient reported a stinging pain in her calf where the venaseal catheter was in place.It was reported the vein closed using a non-medtronic adhesive.The physician reported the blue introducer catheter appeared to have a hole in it at the 55cm mark.The patient was given some pain medication and the pain has resolved.No patient injury was reported.

Manufacturer Narrative

The venaseal system was returned inside a previously opened venaseal box.The loaded venaseal contents included a j-wire, dispensing gun, dilator, venaseal catheter, and blue introducer.All components showed trace amounts of dried adhesive.During visual inspection, no damages or anomalies were noted on the dispensing gun, j-wire, or dilator.The venaseal catheter showed dried adhesive at the distal tip.An inspection of the blue introducer was performed and a hole at the approximate area of the 55cm marker was observed.The hole was inspected under microscope and it was determined that it was not at the laser marking and was located between the laser markings.It appeared to be a puncture.The distal area was intact and could be flapped over distally.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: 8059947
• MDR Text Key: 126890130
• Report Number: 9612164-2018-03154
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: SP-101
• Device Lot Number: 48025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• 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