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

Catalog Number	451503H5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the body shaft of the 5f 100 cm tempo pigtail angiography catheter was found "fractured" before clinical use, when the package was opened, affecting its use.The device was not used in the patient.Another tempo catheter was used to complete the procedure.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).There was no device damage noticed prior to opening the package or difficulty removing the device from the sterile packaging.The device was not prepped after the damage was found.Neither the product nor any of the other devices used with it had been re-sterilized.The product will not be returned.The hospital reported it as an adverse event to the china nmpa directly.Please upgrade this case to ae.
Additional Manufacturer Narrative
As reported, the body shaft of the 5f 100 cm tempo pigtail angiography catheter was found "fractured" before clinical use, when the package was opened, affecting its use.The device was not used in the patient.Another tempo catheter was used to complete the procedure.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).There was no device damage noticed prior to opening the package or difficulty removing the device from the sterile packaging.The device was not prepped after the damage was found.Neither the product nor any of the other devices used with it had been re-sterilized.The device was not returned for evaluation.Without the return of the device or images for analysis, the reported customer event ¿catheter (body/shaft)-cracked¿ could not be confirmed.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 d4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 19363264
• Report Number: 9616099-2024-00164
• Device Sequence Number: 3798496
• Product Code: DQO
• UDI-Device Identifier: 10705032008273
• UDI-Public: (01)10705032008273(17)261130(10)18267077
• 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): 08/27/2024

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 Catalogue Number: 451503H5
• Device Lot Number: 18267077
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 65 KG