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

Catalog Number	451506V0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: TEMPO
• Common Device Name: 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 ; 7863138372
• MDR Report Key: 19201282
• Report Number: 9616099-2024-00130
• Device Sequence Number: 7952293
• Product Code: DQO
• UDI-Device Identifier: 10705032008396
• UDI-Public: (01)10705032008396(17)241031(10)18066986
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 06/06/2024; 08/26/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/12/2024; 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN MULTIPURPOSE CATHETER
• Patient Sex: Unknown
• Patient Ethnicity: Hispanic
• Patient Race: White