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 08/30/2022

Event Type  malfunction  

Manufacturer Narrative

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.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the hub of a 4f vertebral tempo catheter appeared faulty; in that it was incredibly difficult to attach a luer lock syringe to the end of it without shearing off any plastic.The failure occurred during prep.There was no report patient injury.This was a neurocoiling case.The device was stored, handled, and prepped as per instructions for use (ifu).There device was inspected prior to use for damages and there were no damages noted at that time.There was no damage noted to the packaging of the device.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, the hub of a 4f vertebral tempo catheter appeared faulty; in that it was incredibly difficult to attach a luer lock syringe to the end of it without shearing off any plastic.The failure occurred during prep.There was no report patient injury.This was a neuro coiling case.The device was stored, handled, and prepped as per instructions for use (ifu).The device was inspected prior to use for damages and there were no damages noted at that time.There was no damage noted to the packaging of the device.One non-sterile unit of catheter cath tempo 4f ver 135 degree 100cm was received for analysis.During visual inspection, no anomalies were noted on the device.Dimensional analysis was performed to verify the correct outer diameter thread and found within specification.An attempt to connect the unit with a lab sample syringe was successfully performed with no difficulties noted.Additionally, a flush test was performed to determine if the connection was effective, and no leakage or other anomaly was noted.The reported event by the customer as ¿luer hub - catheters ¿ incompatibility/fit - with syringe¿ was not confirmed since the device was successfully connected to a lab sample syringe with no difficulty noted.Handling factors 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.

Manufacturer Narrative

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.

• Brand Name: CATH TEMPO 4F VER 135 DEGREE 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; 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: 15480302
• MDR Text Key: 303557813
• Report Number: 9616099-2022-06014
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032007856
• UDI-Public: (01)10705032007856(17)250228(10)18092072
• Combination Product (y/n): N
• 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,Followup
• Report Date: 10/25/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 09/29/2022; 10/21/2022
• Supplement Dates FDA Received: 10/21/2022; 10/25/2022
• 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