MAUDE Adverse Event Report: LEADER CATH; INTRAVASCULAR CATHETER

Model Number 115.090

Device Problems Break (1069); Material Fragmentation (1261); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/08/2021

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 results of this investigation are pending and will be communicated to fda within 30 days of its conclusion via follow up mdr.The batch review of this batch shows that the product is compliant with its specification.There is no deviation.The tensile strength of the catheters is compliant.Furthermore, the catheter broke 10 days after its insertion.The patient was restless and confused.Therefore, it seems that a tensile fracture occurred.There is no other complaint on this batch.

Event Description

Arterial line has been inserted on (b)(6) 2021.On a patient with covid.Lt was functioning well.The patient became restless and confused on (b)(6).He was restrained.He did pull on restraints.On (b)(6) after handover, the night nurse noted that the patient was bleeding and arterial line cannula was missing.The hub was still sutured to patient wrist.A sonar was done and the cannula was in radial artery.Patient taken to theatre on (b)(6) for exploration and retrieval of the cannula.Lt could not be found circumstances unknown, as the patient is a covid positive patient and staff are not in the patient cubicle the entire time.We have no more information on the state of heath of the patient.

Event Description

Arterial line has been inserted on (b)(6) 2021.On a patient with covid.Lt was functioning well.The patient became restless and confused on (b)(6).He was restrained.He did pull on restraints.On the 8th after handover, the night nurse noted that the patient was bleeding and arterial line cannula was missing.The hub was still sutured to patient wrist.A sonar was done and the cannula was in radial artery.Patient taken to theatre on 9th for exploration and retrieval of the cannula.Lt couid not be found circumstances unknown, as the patient is a covid positive patient and staff are not in the patient cubicle the entire time.We have no more information on the state of heath of the patient.

Manufacturer Narrative

Correction: the manufacturer name and contact office-manufacturing site should be vygon not vygon gmbh.The previous follow-up report listed vygon gmbh.Erroneously.

Manufacturer Narrative

We did not receive the involved sample; we just received a picture of the hub sutured to the patient's arm.We noticed that the entire catheter's line and its anti-kinking sleeve was missing.The length of this catheter is 8 cm, and it is an xro catheter.Therefore, it is very strange that it could not been found by the physician during the exploration.From the description of the incident, the catheter was functioning correctly during 10 days before its fracture.This fracture occurred the day after the patient became restless and confused.He was restrained and he did pull on restraints.The cause of the catheter fracture seems to be traced to excessive tensile and probably to repetitive flexions applied on the tube by the confused patient.Therefore, no corrective action will be intimated at this time.The batch review of this batch shows that the product is compliant with its specification.There is no deviation.The tensile strength of the catheters is compliant.There are no other complaint on this batch.

Event Description

Arterial line has been inserted on (b)(6) 2021.On a patient with covid.Lt was functioning well.The patient became restless and confused on (b)(6).He was restrained.He did pull on restraints.On the 8th after handover, the night nurse noted that the patient was bleeding and arterial line cannula was missing.The hub was still sutured to patient wrist.A sonar was done and the cannula was in radial artery.Patient taken to theatre on 9th for exploration and retrieval of the cannula.Lt couid not be found circumstances unknown, as the patient is a covid positive patient and staff are not in the patient cubicle the entire time.We have no more information on the state of heath of the patient.

• Brand Name: LEADER CATH
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12031461
• MDR Text Key: 257176379
• Report Number: 2245270-2021-00088
• 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,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• 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: 310321EE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2021
• 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
• Patient Outcome(s): Required Intervention