MAUDE Adverse Event Report: CORDIS CORPORATION 4F TEMPO 0.038IN 65CM VERTEBRAL; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number SRD5821

Device Problem Device-Device Incompatibility (2919)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18140941 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 connection between a 4f 0.038in x 65cm vertebral tempo diagnostic catheter and a syringe was impossible.This attempt was made in order to flush the device.The tempo catheter was replaced with another unknown tempo catheter.There were no reports of patient injury.It is unknown if the patient had an infection.The device will not be returned for evaluation, as it was discarded.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h6, and h10.Complaint conclusion: as reported, the connection between a 4f 0.038in x 65cm vertebral tempo diagnostic catheter and a syringe was impossible.This attempt was made in order to flush the device.The tempo catheter was replaced with another unknown tempo catheter.There were no reports of patient injury.It is unknown if the patient had an infection.The device was not returned for analysis.A review of the manufacturing documentation associated with lot 18140941 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿luer hub - catheters ¿ incompatibility/fit - with syringe¿ was not confirmed as the device was not returned for analysis.As such a definitive cause for the event could not be determined, however, handling factors and/or issues with the syringes 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: 4F TEMPO 0.038IN 65CM VERTEBRAL
• 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: 16130426
• MDR Text Key: 307476667
• Report Number: 9616099-2023-06212
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032049146
• UDI-Public: 10705032049146
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SRD5821
• Device Catalogue Number: SRD5821
• Device Lot Number: 18140941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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