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

Catalog Number	451503H5
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the product packaging of the 5f 100cm 5 side-hole (sh) pigtailed tempo diagnostic catheter was damaged, affecting sterility.There were no reports of patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the product packaging of the 5f 100cm 5 side-hole (sh) pigtailed tempo diagnostic catheter was damaged, affecting sterility.The procedure was completed by changing to a new product.There was no reported patient injury.The reported packaging damage occurred on the inner product pouch, which was found compromised.The damage was identified after the product had been received and stored in a cabinet in the lab, prior to use.The product itself was not damaged.The device was stored and prepped according to the instructions for use.A sterile unit of cath tempo 5f pig 100cm 5sh was received properly sealed within its manufacturing pouch.Sterility was not compromised.The device arrived folded within the plastic bag, and kinks were present that matched the folds.Visual and tactile inspection, including the circled area, revealed no damage that would compromise the sterile condition of the packaging.Dimensional analysis of the seal width was conducted and results were within specification.A pull test was not performed since fixtures were unavailable and the complaint did not concern the seal.Inspection of the pouch surface with a vision system showed no damage.Overall, the product evaluation did not indicate a design or manufacturing issue.The reported malfunctions ¿packaging/pouch/box-compromised sterility¿ and ¿packaging/pouch/box-damaged¿ were not seen during evaluation.The exact cause of the event cannot be found; however, storage or handling may be a contributing factor.Information for safety is provided in the product¿s labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿do not use if package is open or damaged.¿ and ¿store in a cool, dark, dry place.¿ based on the available information and product analysis, there is no evidence to suggest 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
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida
• 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: 22630693
• Report Number: 9616099-2025-01208
• Device Sequence Number: 12996034
• Product Code: DQY
• UDI-Device Identifier: 10705032008273
• UDI-Public: (01)10705032008273(17)271031(10)18389347
• 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): 08/28/2025

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: 18389347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 08/17/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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: TEMPO CATHETER
• Patient Sex: Unknown