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

Catalog Number SP-101

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

The photo provided by the customer has been analysed.The photo shows a dilator loaded inside a blue introducer.The distal rim of the introducer showed damage.The introducer material was pushed proximal and showed a possible tear.The venaseal blue introducer, dilator, and j-wire were received.No ancillary devices/components were included.The dilator was inserted inside the blue introducer.The j-wire was inspected and a bend was noted 36 cm from the looped tip.No other damages were noted to the wire.A portion of the distal rim of the introducer was damaged.The rim showed a segment where the material tore and buckled proximally.The diameter of the tip with the introducer inserted was 0.0975¿.This diameter of the distal tip of the dilator with the observed damage exceeds 7f specifications.Damage to the distal tip of the catheter could be seen.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use the venaseal to treat the great saphenous vein as per ifu.It was reported the blue catheter distal tip was observed to be defective, the physician was unable to advance the device smoothly into the patient¿s vessel.Another device was used for the procedure.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: 7063197
• MDR Text Key: 93591382
• Report Number: 9612164-2017-01679
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: SP-101
• Device Lot Number: 46229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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