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

Model Number	N/A
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.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.
Event or Problem Description
As reported, a 5 f tempo aqua 0.038" 65cm catheter began crumbling during a procedure.The catheter was not used at the time of noticing the flaking.A different unknown catheter was used.The patient later expired that day.It is stated that the tech wiped his hands and noticed blue flakes on his gloves and checked the catheter and noticed it was "crumbling", and that none of the catheter flaked off in the patient's body, just on the sterile field.The catheter did not flake off inside the patient¿s body; the flaking occurred on the sterile field and was noticed during the procedure before being passed to the physician.The device was prepped and flushed, with no difficulties encountered during preparation.There was no need to replace the sterile field, gloves, or gown after noticing the flaking.The procedure was a peripheral intervention conducted on an outpatient basis for peripheral artery disease (pad).The patient died due to an access site bleed and exhibited hypotension prior to expiring.The device was not exposed to heat or stored in a dark location, and the facility does not use uv lighting or ozone for sterilization or microbial reduction.The target site was the common iliac artery, and the access site was femoral, with both sides accessed.The user was trained to the device.At the target site, vessel characteristics included severe calcification, 90% stenosis, bifurcation at the iliac ostium, and no tortuosity or acute angle.For access to the target site, the vessel showed severe calcification, 50% stenosis, and no tortuosity, acute angle, or bifurcation.The device was not used for treatment of a chronic total occlusion (cto).The rep stated that she noticed about 17 sterile catheters were flaking in the package.All sterile devices will be returned for analysis, including the one used in the procedure.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.As reported, a 5 f tempo aqua 0.038" 65cm catheter began crumbling during a procedure.The catheter was not used at the time of noticing the flaking.A different unknown catheter was used.The patient later expired that day.It is stated that the tech wiped his hands and noticed blue flakes on his gloves and checked the catheter and noticed it was "crumbling", and that none of the catheter flaked off in the patient's body, just on the sterile field.The catheter did not flake off inside the patient¿s body; the flaking occurred on the sterile field and was noticed during the procedure before being passed to the physician.The device was prepped and flushed, with no difficulties encountered during preparation.There was no need to replace the sterile field, gloves, or gown after noticing the flaking.The procedure was a peripheral intervention conducted on an outpatient basis for peripheral artery disease (pad).The patient died due to an access site bleed and exhibited hypotension prior to expiring.The device was not exposed to heat or stored in a dark location, and the facility does not use uv lighting or ozone for sterilization or microbial reduction.The target site was the common iliac artery, and the access site was femoral, with both sides accessed.The user was trained to the device.At the target site, vessel characteristics included severe calcification, 90% stenosis, bifurcation at the iliac ostium, and no tortuosity or acute angle.For access to the target site, the vessel showed severe calcification, 50% stenosis, and no tortuosity, acute angle, or bifurcation.The device was not used for treatment of a chronic total occlusion (cto).The rep stated that she noticed about 17 sterile catheters were flaking in the package.All sterile devices will be returned for analysis, including the one used in the procedure.Twenty-three devices were returned for analysis and were reviewed under complaints (b)(4).The cath tempo 4f ber ii 100cm sterile unit was received in the original pouch, folded inside a plastic bag, and was unpacked to perform visual inspection.Inspection confirmed that the pouch seals were intact and sterility was not compromised.The catheter was inspected with focus on the strain relief, where degradation and yellowish discoloration on the hub were observed.No additional damage or anomalies were identified in the remaining components of the device.Degradation of this nature is commonly associated with exposure to environmental factors such as ultraviolet radiation, thermal stress, or chemical agents; however, the specific root cause of the observed degradation could not be determined based on the product evaluation.The crumbling and flaking reported by the customer were observed during the product evaluation and were attributed to the malfunctions ¿catheter (body/shaft) ¿ degradation¿ and ¿strain relief ¿ degradation.¿ seventeen devices exhibited degradation of the catheter body, five devices exhibited degradation of the strain relief, and one device exhibited degradation affecting both the catheter body and the strain relief.Degradation of this nature is commonly associated with exposure to environmental factors such as ultraviolet radiation, thermal stress, or chemical agents; however, the specific root cause of the observed degradation could not be determined based on the available information.Potential contributing factors may include storage or handling conditions at the reporting facility, distribution or storage conditions prior to use, or other factors occurring outside the manufacturer¿s direct control.Users are trained to inspect products for signs of damage prior to and during use, and any product exhibiting damage is not to be used.Product labeling includes safety information intended to inform users of these 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.¿ based on the available information and product analysis, the cause of the observed degradation could not be determined; therefore, a risk assessment has been initiated to further review potential contributing factors.No further action will be taken at this time.

• 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: 23478275
• Report Number: 9616099-2025-01747
• Device Sequence Number: 10228737
• Product Code: DQO
• UDI-Device Identifier: 10705032007863
• UDI-Public: (01)10705032007863(17)270831(10)18371888
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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 Model Number: N/A
• Device Catalogue Number: 451415H0
• Device Lot Number: 18371888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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: UNKNOWN CATHETER
• Patient Age: 80 YR
• Patient Sex: Female