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

Catalog Number	451531H0
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the body of a 5f tempo angiographic catheters was peeling off, appearing as though it was decomposing.There was no reported patient injury.It was further reported that additional devices from the same lots and skus exhibited similar peeling, with approximately nineteen devices affected.It was confirmed that the remaining devices were sterile and exhibited the same failure.Devices are stored in the warehouse along with other medical devices.Ozone is not used to disinfect, and it is not used in any areas such as procedure or storage rooms.Four images were provided, showing blue flakes on a blood-soaked surgical towel, cracks on the catheter body and strain relief, and yellowish discoloration to the hub.The devices will be returned for evaluation.
Additional Manufacturer Narrative
The device was returned for evaluation; however, the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
The device was returned.
Additional Manufacturer Narrative
As reported, the body of 5f tempo angiographic catheters was peeling off, appearing as though it was decomposing.It was further reported that additional devices from the same lots and skus exhibited similar peeling, with approximately nineteen devices affected.It was confirmed that the remaining devices were sterile and exhibited the same failure.Devices are stored in the warehouse along with other medical devices.Ozone is not used to disinfect, and it is not used in any areas such as procedure or storage rooms.The cath tempo 5f sim 2 100cm device was received as one sterile unit in the original pouch placed inside a plastic bag.The unit was unpacked to perform a visual inspection, and the pouch seals were intact with no evidence of compromised sterility.Visual inspection of the catheter identified a degradation condition on the body of the unit, while the strain relief did not present a degradation condition.No other outstanding details or anomalies were observed.During the product evaluation of the reported complaint, the unit was confirmed to exhibit degradation characteristics on the body of the catheter, and no other anomalies were detected; based on these findings, the complaint was escalated for further investigation.The reported ¿catheter (body/shaft) ¿ degradation¿ was observed during the product evaluation; however, ¿strain relief ¿ degradation¿ was not observed.Based on the available information, the specific cause of the degradation could not be determined.Potential contributing factors include storage or handling conditions within the reporting facility or factors associated with the manufacturing process of the unit.Users are trained to inspect products for signs of damage prior to and during use, and any product showing damage is not to be used.The product labeling includes information for safety intended to make users aware of such risks.According to the instructions for use (ifu), ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Do not expose to organic solvents.¿ while this guidance mitigates risks associated with storage and handling, it does not eliminate the potential for degradation.Because a potential link to the manufacturing process could not be excluded, an investigation has been initiated to further evaluate potential contributing factors and implement further actions as appropriate.No additional actions will be taken at this time.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014 2802
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 23509281
• Report Number: 9616099-2025-01806
• Device Sequence Number: 9622032
• Product Code: DQO
• UDI-Device Identifier: 10705032008587
• UDI-Public: (01)10705032008587(17)271231(10)18408562
• 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): 01/29/2026

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: 451531H0
• Device Lot Number: 18408562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 11/26/2025; 01/22/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/01/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2025
• 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 Sex: Unknown