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

Catalog Number SP-101

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 08/12/2019

Event Type  malfunction  

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 patient treatment.Ifu was followed.It is reported the catheter tip was cracked when the introducer entered the vessel and the patient complained of pain.A new kit was opened to complete the procedure.No adverse event reported.

Manufacturer Narrative

Additional information: moderate resistance was experienced when advancing the sheath.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the venal seal kit was returned within a clear biohazard bag and within its transportation hoop.Components returned include: dispenser gun, two syringes, a vial, blue introducer, a catheter and dilator.The dilator was observed inserted within the blue introducer.No abnormalities were noted on the catheter and dilator.Visual inspection of the catheter revealed no damage to the tip.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: two images were received for evaluation.Visual inspection of the image reveal fracture of the introducer distal tip.The component was not returned for evaluation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 8887065
• MDR Text Key: 154108140
• Report Number: 9612164-2019-03359
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup,Followup,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: SP-101
• Device Lot Number: 54147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 10/01/2019; 10/27/2019; 11/13/2019; 12/10/2019
• Supplement Dates FDA Received: 10/02/2019; 10/30/2019; 11/14/2019; 12/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2019
• 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