MAUDE Adverse Event Report: CORDIS CORPORATION TEMPO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 451506V0

Device Problem Crack (1135)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

As reported, when a 5f 65cm tempo guiding catheter was being passed to the technologist, a fracture was observed in it's "middle part".A new unknown multipurpose catheter was used.There was no reported patient injury.The issue occurred during preparation of the device.The device was stored and prepped per the instructions for use (ifu).The device was pulled from the packaging according to the ifu.The device was torqued by the hub.Images are available for review.The device is being returned for evaluation.

Manufacturer Narrative

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

Event Description

As reported, when a 5f 65cm tempo guiding catheter was being passed to the technologist, a fracture was observed in it's "middle part".A new unknown multipurpose catheter was used.There was no reported patient injury.The issue occurred during preparation of the device.The device was stored and prepped per the instructions for use (ifu).The device was pulled from the packaging according to the ifu.The device was torqued by the hub.Images are available for review however not yet provided.The device was not returned for evaluation as previously expected.

Manufacturer Narrative

As reported, when a 5f 65cm tempo guiding catheter was being passed to the technologist, a fracture was observed in its "middle part".A new unknown multipurpose catheter was used.There was no reported patient injury.The issue occurred during preparation of the device.The device was stored and prepped per the instructions for use (ifu).The device was pulled from the packaging according to the ifu.The device was torqued by the hub.The device was not returned for evaluation as previously expected.Three pictures were submitted for analysis and no signs of cracks, or any other damages can be seen in the provided images.The reported " catheter (body/shaft) - cracked¿ was not confirmed as no visual evidence of a cracked condition can be observed in the images.Therefore, the root cause of the failure experienced by the customer could not be conclusively determined during the analysis.Storage or 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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ based on the available information, 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: TEMPO
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 19201282
• MDR Text Key: 341303089
• Report Number: 9616099-2024-00130
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032008396
• UDI-Public: 10705032008396
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 04/29/2024

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: 451506V0
• Device Lot Number: 18066986
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2021
• 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 MULTIPURPOSE CATHETER
• Patient Ethnicity: Hispanic
• Patient Race: White