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

Catalog Number	451506P0
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, some particles were found inside a 5f tempo 125 cm multi-purpose a (mpa) catheter.There was no reported patient injury.The event was reported to have occurred approximately 4 to 6 weeks prior to notifying the rep via email.During which time the devices had been collected but remained unused.The specific part of the device affected is unknown, as the devices were never opened due to visible plastic particles observed through the packaging.The issue was first noted when they were about to open the first of five devices in the box, after the products had been received and stored in the lab using normal hangers.Although the devices were handled appropriately, they were not opened because of the visible contamination.Three (3) images were received showing a catheter inside a pouch.Blue polymer flakes are visible within the packaging, and a portion of the strain relief appears to be missing, suggesting it may be the source of the flakes.The device (s) are expected to 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.
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 for evaluation.
Additional Manufacturer Narrative
As reported, some particles were found inside a 5f tempo 125 cm multi-purpose a (mpa) catheter.There was no reported patient injury.The event was reported to have occurred approximately 4 to 6 weeks prior to notifying the rep via email.During which time, the devices had been collected but remained unused.The specific part of the device affected is unknown, as the devices were never opened due to visible plastic particles observed through the packaging.The issue was first noted when they were about to open the first five devices in the box, after the products had been received and stored in the lab using normal hangers.Although the devices were handled appropriately, they were not opened because of the visible contamination.Three (3) images were received showing a catheter inside a pouch.Blue polymer flakes are visible within the packaging, and a portion of the strain relief appears to be missing, suggesting it may be the source of the flakes.One sterile cath tempo 5f mp a1 (i) 125cm catheter unit received coiled inside a transparent plastic bag.The other four devices were not returned.Visual inspection of the returned device revealed a degraded strain relief with blue flakes present inside the sealed packaging, along with a yellowish discoloration on the hub and a crack on the catheter body.No other visible damage or anomalies were seen on the returned components.Amplified images confirmed the observed degradation.A yellowish discoloration was also noted at the back of the pouch label, prompting ftir analysis.The ftir spectra showed signs of degradation in the label, including a shifted and broadened carbonyl band, reduced c¿o ether intensity, chain scission, and adhesive bond cleavage, likely due to uv exposure and oxidation.The spectral evidence also showed degradation of the paper substrate, consistent with the yellowing observed.All five devices are from the same lot and product history record (phr) review of lot 18112096 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 seen on the returned device during the product analysis.However, it could not be substantiated for the other four devices because they were not returned for evaluation.The exact cause of the degradation is unknown.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products 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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ based on the available information and product analysis, the cause of the strain relief degradation could not be found; however, it is potentially related to the manufacturing process of the unit.Therefore, an investigation has been started to further review the potential causes.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 60th avenue; miami lakes, florida 33014
• 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: 22080817
• Report Number: 9616099-2025-00864
• Device Sequence Number: 18318664
• Product Code: DQO
• UDI-Device Identifier: 10705032008358
• UDI-Public: (01)10705032008358(17)250430(10)18112096
• 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): 08/27/2025

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 Expiration Date: 04/30/2025
• Device Catalogue Number: 451506P0
• Device Lot Number: 18112096
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 08/22/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/12/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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: UNKNOWN.
• Patient Sex: Unknown