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 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18110854 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, during the use of a 4f 100cm 135-degree tempo vertebral diagnostic catheter, an attempt to connect a 10mm syringe to the catheter was made but it wasn¿t a tight fit.A second 10mm syringe was used to connect but the same issue occurred.As a result, the device was recalled and there was no reported injury to the patient.This was during a procedure to treat a chronic totally occluded (cto) lesion in the superficial femoral artery (sfa) in which a contralateral approach was used.Additional information was requested but was not provided.The device was not returned as expected.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b3, d8, d9, g3, g4, g6, h1, h2, h3, and h10 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.Section d3 was updated to provide the correct spelling of "cordis corporation".

Event Description

As reported, during the use of a 4f 100cm 135-degree tempo vertebral diagnostic catheter, an attempt to connect a 10mm syringe to the catheter was made but it wasn¿t a tight fit.A second 10mm syringe was used to connect but the same issue occurred.As a result, the device was recalled and there was no reported injury to the patient.This was during a procedure to treat a chronic totally occluded (cto) lesion in the superficial femoral artery (sfa) in which a contralateral approach was used.Additional information was requested but was not provided.The device has now been returned.

Manufacturer Narrative

Complaint conclusion: as reported, during the use of a 4f 100cm 135-degree tempo vertebral diagnostic catheter, an attempt to connect a 10mm syringe to the catheter was made but it wasn¿t a tight fit.A second 10mm syringe was used to connect but the same issue occurred.As a result, the device was recalled and there was no reported injury to the patient.This was during a procedure to treat a chronic totally occluded (cto) lesion in the superficial femoral artery (sfa) in which a contralateral approach was used.Additional information was requested but was not provided.The device has now been returned.One non-sterile unit of a cath tempo 4f ver 135 degree 100cm was received inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.Per visual analysis, there was a catheter with a syringe attached to the luer hub and another syringe returned.No anomalies were noted during visual inspection.Per dimensional analysis the hub thread outer diameter was measured and found to be within specification.Due to the reported event of an inability to connect with a syringe, an attempt to connect the unit with the two syringes returned for evaluation and a lab sample syringe was performed.Only with one of the returned syringes the connection was not possible.After the connection, a flushing test was performed, and no leakage or anomaly was noted on the syringes where the connection was possible.A device history record review of lot 18110854 was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan and that there were no anomalies during the manufacturing.The reported customer complaint of ¿luer hub - catheters ¿ incompatibility/fit - with syringe¿ was confirmed since the device could not be connected with one of the syringes returned for evaluation.However, the unit was connected to a lab sample syringe and to the other returned syringe, and no difficulty was noted.The exact cause for the difficulties encountered by the customer could not be determined, as the catheter was successfully connected to two other syringes.It is possible that the issue was with the returned syringe.According to the instructions for use, which is not intended as a mitigation of risk ¿before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.¿ this step would ensure that there is a proper connection established between a syringe and the luer hub.Neither the product history review nor the analysis results suggest that the failure experienced by the customer could be related to the manufacturing process, therefore no 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; 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: 16214680
• MDR Text Key: 308459080
• Report Number: 9616099-2023-06223
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032007856
• UDI-Public: (01)10705032007856(17)250430(10)18110854
• 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,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• 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: 18110854
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• 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.; UNKNOWN.