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

Catalog Number SP-101

Device Problem Biocompatibility (2886)

Patient Problem Anaphylactic Shock (1703)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal for patient treatment for the great saphenous vein (gsv).It is unknown if it was the left or right, but it was venous.Only one leg was treated.Ifu was followed and the device was prepped without issue.The patient was administered antibiotics prior to the procedure.No sedation (precede) was used.0.1cc of local anesthesia (xylocaine) was applied at the insertion site.The location of the catheter tip prior to initial delivery of adhesive was periphery 5 cm from sfj.There was no compression of the gsv.During the treatment, immediately after the injection, about 4-5 minutes after the start of treatment (3rd aliquot), the patient complained of itching in the upper body.Treatment was continued and the fourth aliquot was delivered, symptoms such as blood pressure, decreased saturation, redness, and urticaria appeared.Blood pressure decreased from 110/61 to 84/48 due to the appearance of symptoms such as redness.The patient¿s pulse increased from 60 to 90.Oxygen was increased to 5l/min.Anaphylaxis was suspected.The treatment was discontinued and subcutaneous injection of bosmin was administered.Adrenal hormones (solmedrol) were also administered intravenously.The patient was transferred to another hospital and hospitalized overnight and discharged the following day.It is reported the event was not caused by the product.The cause of the anaphylactic shock is not identified.The physician believes it is not caused by venaseal as the adhesive is still left in the patient's leg; however, it is unknown to confirm if the venaseal was a cause.It is suspected it may be other medications such as local anesthesia (xylocaine), pethidine or antibiotics administered before the surgery.The patient is no longer on steroid but has no further symptoms.10 cm of the vein was treated.The patient was hospitalized for one night and discharged the following day after the procedure.No further injury reported.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11875700
• MDR Text Key: 252365558
• Report Number: 9612164-2021-02052
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: SP-101
• Device Lot Number: 61616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2021
• Date Device Manufactured: 11/03/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR