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

Model Number SP-101

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

Two images were received: image 1 revealed a guidewire inserted into a blue dilator.The image also revealed the guidewire is also inserted into the catheter from the white transportation hoop.Image 2 revealed a damaged guidewire.The image shows tensile stretching of the guidewire resulting from tearing of the coating on guidewire.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician intended to use venaseal to treat the great saphenous vein as per ifu.It was reported the guidewire was advanced to the junction and the venaseal sheath and dilator was advanced over the wire to the junction.The wire was withdrawn from the sheath and it was noted that the wire was frayed.The wire was removed from the patient as a precautionary measure.The procedure was completed with another venaseal and no patient 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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7376755
• MDR Text Key: 103660811
• Report Number: 9612164-2018-00586
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: SP-101
• Device Lot Number: 44321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Date Device Manufactured: 07/12/2016
• 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