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

Catalog Number	451514H0
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
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 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 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.
Additional Manufacturer Narrative
Corrected data: lot and catalog numbers: 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.Three sterile devices, cath tempo 5f ver 135° 100cm, were received for analysis in their original sealed pouches and placed in a single plastic bag.The device associated with this complaint was unpacked for evaluation.During visual inspection, the strain relief was found to be partially pulverized and severely cracked, with portions still adhered to the catheter.A yellowish discoloration was noted on the catheter hub.No other anomalies were detected during visual examination.A microscopic examination was performed on the strain relief, catheter body, and catheter hub areas to closely evaluate the condition of the strain relief and further assess the discoloration observed on the hub.Under microscopic review, the strain relief demonstrated severe cracking and partial pulverization, and the catheter body exhibited extensive cracking along its length.The partial discoloration noted during visual inspection was confirmed on the hub during microscopic examination.No additional anomalies were detected during microscopic evaluation.During product evaluation of the reported complaint, it was confirmed that the unit exhibited degradation characteristics on the strain relief and the body of the device.Documentation related to the original escalation is maintained within (b)(4), and the reassignment was performed to align the returned device with the appropriate complaint record without impacting the integrity of the investigation or overall assessment.The reported ¿catheter (body/shaft) ¿ degradation¿ and ¿strain relief ¿ degradation¿ was observed during the product evaluation.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: 23513310
• Report Number: 9616099-2025-01828
• Device Sequence Number: 9667235
• Product Code: DQO
• UDI-Device Identifier: 10705032008587
• UDI-Public: (01)10705032008587(17)251031(10)18161497
• 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): 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 Catalogue Number: 451514H0
• Device Lot Number: 18361313
• Was Device Available for Evaluation?: Yes
• 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: 03/03/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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