MAUDE Adverse Event Report: VYGON LEADER-CATH; INTRAVASCULAR DIAGNOSTIC CATHETER

Model Number 115.090

Device Problem Infusion or Flow Problem (2964)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

As the batch number is unknown and the involved device not available, no investigation can be done.

Event Description

After 5 days in situ, the line stopped flushing and the trace was no longer visible.The line was reviewed and removed , it was noted that approx.5-6cm of the line remained in situ.The vascular team reviewed the patient and he returned to theatre to have the remaining line removed.The involved sample is not available and the batch has not been registered.We received no further information.

Manufacturer Narrative

As the batch number is unknown and the involved device not available, no investigation can be done.There will be no further report.

Event Description

After 5 days in situ, the line stopped flushing and the trace was no longer visible.The line was reviewed and removed , it was noted that approx.5-6cm of the line remained in situ.The vascular team reviewed the patient and he returned to theatre to have the remaining line removed.The involved sample is not available and the batch has not been registered.We received no further information.

• Brand Name: LEADER-CATH
• Type of Device: INTRAVASCULAR DIAGNOSTIC CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• MDR Report Key: 8165960
• MDR Text Key: 130388286
• Report Number: 2245270-2018-00094
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K813142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 115.090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention