MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F VER 135 DEGREE 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451414H0

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2022

Event Type  malfunction  

Event Description

As reported, there was resistance when attaching the syringe to the hub of two 4f tempo vertebral 100cm diagnostic catheters.It was noticed that the syringe had resistance connecting to the hub during prep.Another unknown vertebral catheter was opened and worked fine.There was no reported patient injury.The device was inspected in the package prior to opening.The device was not resterilized.The device was opened in a sterile field.The user was trained to the device.The device was stored per labeling.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The devices will be returned for evaluation.

Manufacturer Narrative

This report is related to report #: 9616099-2022-06070.A review of the manufacturing documentation associated with lot 18092072 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

This report is related to report # 9616099-2022-06070.As reported, there was resistance when attaching the syringe to the hub of two 4f tempo vertebral 100cm diagnostic catheters.It was noticed that the syringe had resistance connecting to the hub during prep.Another unknown vertebral catheter was opened and worked fine.There was no reported patient injury.The device was inspected in the package prior to opening.The device was not resterilized.The device was opened in a sterile field.The user was trained to the device.The device was stored per labeling.Two non-sterile units of catheter cath tempo 4f ver 135 degree 100cm were received for analysis.The units were randomly identified as unit 1 and unit 2.Unit one was evaluated under complaint (b)(4) and unit 2 was evaluated under (b)(4).(b)(4): during visual inspection, no anomalies were noted on the device (brite tip/distal tip, body/shaft nor the hub).Dimensional analysis was performed to verify the correct thread outer diameter and found within specification.An attempt to connect the unit with a lab sample syringe was successfully performed and no difficulty was noted.A flushing test was performed, and no leakage or anomaly was noted.A product history record (phr) review of lot 18092072 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.(b)(4): during visual inspection, no anomalies were noted on the device (brite tip/distal tip, body/shaft nor the hub).Dimensional analysis was performed to verify the correct thread outer diameter and found within specification.An attempt to connect the unit with a lab sample syringe was successfully performed and no difficulty was noted.A flushing test was performed, and no leakage or anomaly was noted.A product history record (phr) review of lot 18092072 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The events reported by the customer as ¿luer hub - catheters ¿ incompatibility/fit - with syringe¿ was not confirmed for either device since they were connected to a lab sample syringe with no difficulty or leaks noted.Handling factors and/or issues with the syringe may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: CATH TEMPO 4F VER 135 DEGREE 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; cordis corporation; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16084116
• MDR Text Key: 306790876
• Report Number: 9616099-2023-06199
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 451414H0
• Device Catalogue Number: 451414H0
• Device Lot Number: 18092072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 01/02/2023
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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
• Treatment: UNKNOWN VERTEBRAL CATHETER