MAUDE Adverse Event Report: CORDIS US CORP. TEMPO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 451431H0

Device Problem Crack (1135)

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

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 4f 100cm tempo catheter sidewinder ii (sim 2) catheter was observed fractured.There was no reported patient injury.The device is expected to be returned for evaluation.

Manufacturer Narrative

Upon review, the event reported was reclassified from a reportable malfunction to a non-reportable event.The device did not fracture; it was kinked during prep and there was no death or serious injury associated with the event.Based on the additional information provided, this event no longer meets the definition of a reportable malfunction that requires submission of a regulatory report.

Event Description

As reported, a 4f 100cm tempo catheter sidewinder ii (sim 2) catheter was observed bent and not fractured during prep as it was initially reported; there was no device detachment.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu; there was no difficulty experienced in prepping the device.

• Brand Name: TEMPO
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 19059548
• MDR Text Key: 339593106
• Report Number: 9616099-2024-00107
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032007948
• UDI-Public: 10705032007948
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/10/2024

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 Catalogue Number: 451431H0
• Device Lot Number: 18168806
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2022
• 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: NO APLICA