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

Model Number 115.090

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

The failed sample will be returned to vygon for device evaluation as part of the complaint investigation.The results of this investigation are still pending, and will be communicated to fda within 30 days of its conclusion.The batch review of this batch shows that the product is compliant to its specification.The tensile strength is conform to iso norm.

Event Description

Patients artery scanned, device still in situ in radial artery, advice sort from vascular consultant.Patient review by vascular consultant (b)(6) 2020 due to the patients poor clinical condition no further action is required and the retention of the arterial line is unlikely to have a direct impact on the patient.The patient is frail and elderly post hemiarthroplasty surgery and has cognitive impairment with lack of ability to retain short term memory.The orthopaedic team have been asked to ensure that the retained of the part is clearly outlined within communication to the patients gp and the reason to leave the remaining part in situ.The patients nok have been spoken to and are aware of the impact to the patient and the advice offered from the vascular team.

Event Description

Patients artery scanned, device still in situ in radial artery, advice sort from vascular consultant.Patient review by vascular consultant (b)(6) 2020 due to the patients poor clinical condition no further action is required and the retention of the arterial line is unlikely to have a direct impact on the patient.The patient is frail and elderly post hemiarthroplasty surgery and has cognitive impairment with lack of ability to retain short term memory.The orthopaedic team have been asked to ensure that the retained of the part is clearly outlined within communication to the patients gp and the reason to leave the remaining part in situ.The patients nok have been spoken to and are aware of the impact to the patient and the advice offered from the vascular team.

Manufacturer Narrative

During the investigation, the reported fractured of the arterial line was confirmed.On examination under the microscope, a stretched and uneven aspect of the fracture surfaces was identified.From previous investigations, we are aware that these characteristics are associated with the occurrence of a tensile fracture having occurred.From the reporting form we understand that the incident occurred on the day of insertion.We would therefore recommend considering the possible causes of stress and flexion that may have been placed on the catheter (for example, movement of an extension set, during a dressing change).To prevent future reoccurrence of this issue, it may be worth considering the securement method used.Unfortunately, we are not aware of how the device was secured.The batch review of this batch shows that the product is compliant to its specification.The tensile strength is conform to iso norm.In evaluating our data registration system, we can confirm that we have not received any additional reports of a similar nature for the product code: 0115803 during 2019 and to date at 2020.This event seems not to be linked to a quality defect of the device.

• Brand Name: LEADER-CATH
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• MDR Report Key: 9762533
• MDR Text Key: 181402359
• Report Number: 2245270-2020-00011
• 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: 07/22/2020

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 Catalogue Number: 115.090
• Device Lot Number: 8094298 OR 8095049
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention