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

Catalog Number	451506P0
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the first time the 5f 125cm temps mp a1 contrast catheter went towards the blood vessel, after removing it, the operator wiped the blood on the tube with gauze, and the tip end of the tube broke off with a gentle rubbing.There was no reported injury to the patient.The device was prepared as specified by the instructions for use (ifu).There was no apparent damage to the device noticed prior to use.The vessel had no tortuosity, and there was no resistance encountered while advancing over the guidewire.The device will be returned for evaluation.Device images showing the tip broken off are not available.
Additional Manufacturer Narrative
As reported, the first time the 5f 125cm tempo mp a1 contrast catheter went towards the blood vessel; after removing it, the operator wiped the blood on the tube with gauze, and the tip end of the tube broke off with a gentle rubbing.There was no reported injury to the patient.The device was prepared as specified by the instructions for use (ifu).There was no apparent damage to the device noticed prior to use.The vessel had no tortuosity, and there was no resistance encountered while advancing over the guidewire.The device was not returned for evaluation as multiple attempts were made without success.Device images showing the separated tip are not available.Without the return of the device or images for analysis, the reported customer event ¿brite tip/distal tip-separated¿ could not be confirmed.Handling or procedural 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, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ 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.
Event or Problem Description
As reported, the first time the 5f 125cm tempo mp a1 contrast catheter went towards the blood vessel, after removing it, the operator wiped the blood on the tube with gauze, and the tip end of the tube broke off with a gentle rubbing.There was no reported injury to the patient.The device was prepared as specified by the instructions for use (ifu).There was no apparent damage to the device noticed prior to use.The vessel had no tortuosity, and there was no resistance encountered while advancing over the guidewire.The device will not be returned for evaluation as multiple attempts were made without success.Device images showing the tip broken off are not available.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US. CORP; 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: 20279813
• Report Number: 9616099-2024-00310
• Device Sequence Number: 7453990
• Product Code: DQO
• UDI-Device Identifier: 10705032008358
• UDI-Public: (01)10705032008358(17)270131(10)18290488
• 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
• Report Date (Section B): 10/15/2024

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 Catalogue Number: 451506P0
• Device Lot Number: 18290488
• Was Device Available for Evaluation?: No
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2024
• 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: THE TERUMO 8F FEMORAL SHEATH.
• Patient Age: 69 YR
• Patient Sex: Male