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

Catalog Number	451401V5
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
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.The healthcare professional stated that the catheter had been inserted into the patient when the peeling was noticed.Manual intervention was not required, and another tempo catheter was used to complete the procedure.There was no reported patient injury.The catheter was used during an embolization procedure for a splenic artery aneurysm.No abnormalities were noticed when the catheter was opened and introduced into the patient.Its condition was only discovered upon removal.Although the patient appeared to suffer no consequences, it cannot be definitively ruled out that residues may have entered the bloodstream.The device was stored, handled, and prepped according to the instructions for use (ifu).There was no patient hospitalization or extension due to the event.The device was not exposed to ultraviolet (uv) light during storage and was discarded at site.Sterile devices are expected to be returned for evaluation.
Additional Manufacturer Narrative
A product history record (phr) review of lot 18167680 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.Additional information is pending and will be submitted within 30 days upon receipt.Correction: the device was discarded at site.
Event or Problem Description
Sterile device was received for evaluation.
Additional Manufacturer Narrative
A sterile 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.
Additional Manufacturer Narrative
As reported, the body of a 5f tempo angiographic catheters was peeling off, appearing as though it was decomposing.The healthcare professional stated that the catheter had been inserted into the patient when the peeling was noticed.Manual intervention was not required, and another tempo catheter was used to complete the procedure.There was no reported patient injury.The catheter was used during an embolization procedure for a splenic artery aneurysm.No abnormalities were noticed when the catheter was opened and introduced into the patient.The condition was discovered upon removal.Although the patient appeared to suffer no consequences, it cannot be definitively ruled out that residues may have entered the bloodstream.The device was stored, handled, and prepped according to the instructions for use (ifu).There was no patient hospitalization or extension due to the event.The device was not exposed to ultraviolet (uv) light during storage and was discarded at site.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.(b)(4).Four photos were attached to (b)(4); three of the photos most likely correspond to the complaint (b)(4).The photos show a used diagnostic catheter device without strain relief, with blue flakes present at the surgical drape, and with cracks along the body shaft; these characteristics are visual evidence of degradation of the strain relief and catheter body.No other anomalies or notable details were observed in the images.A product history record (phr) review of lot 18167680 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿strain relief ¿ degradation¿ was found on one of the devices.The reported ¿catheter (body/shaft) ¿ degradation¿ was found on 9 of the devices.The reported ¿¿strain relief ¿ degradation¿ and ¿catheter (body/shaft) ¿ degradation¿ was found on 10 of the devices.Based on the available information, the specific cause of the degradation could not be determined.Potential contributing factors include storage or handling conditions at the reporting facility, as well as factors related to the manufacturing process.Users are trained to inspect products for signs of damage prior to and during use, and any product exhibiting damage should not be used.The product labeling includes safety information intended to inform users 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 is intended to mitigate 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 contributing factors and determine whether additional actions are warranted.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: 23509089
• Report Number: 9616099-2025-01802
• Device Sequence Number: 9785879
• Product Code: DQO
• UDI-Device Identifier: 10705032007641
• UDI-Public: (01)10705032007641(17)251031(10)18167680
• 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,Followup
• Report Date (Section B): 03/05/2026

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 451401V5
• Device Lot Number: 18167680
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 11/26/2025; 12/19/2025; 03/04/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/01/2025; 12/19/2025; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• 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: N/A.
• Patient Sex: Unknown