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

Catalog Number	451503H5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the proximal segment of the tubing of a 5f 100cm 5 side hole (sh) pigtail (pig) tempo angiographic catheter was found to be incomplete before the patient's interventional procedure.There was no reported patient injury.The event was reported to the china national medical products administration (nmpa) as an adverse event.The device 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
Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was returned for evaluation.
Additional Manufacturer Narrative
A product history record (phr) review of lot 18370302 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.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.
Additional Manufacturer Narrative
As reported, the proximal segment of the tubing of a 5f 100cm 5 side hole (sh) pigtail (pig) tempo angiographic catheter was found to be incomplete before the patient's interventional procedure.There was no reported patient injury.The event was reported to the china national medical products administration (nmpa) as an adverse event.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.A non-sterile unit of catheter cath tempo 5f pig 100cm 5sh was received coiled inside a transparent plastic bag and unpacked to proceed with product evaluation.Visual inspection of the catheter and distal tip found the device to be intact, with no separation, damage, or anomalies observed on the distal tip or any returned device components upon unaided eye inspection.Microscopic analysis was supported by amplified images of the evaluated areas, and no evidence was found indicating that the distal tip was separated.Based on the visual and microscopic analyses performed, the received unit did not present evidence of separation of the distal tip, and no damage or anomalies were identified on the distal tip or any returned device components.No evidence of manufacturing defects or assembly-related issues was identified, and the product analysis does not indicate that the reported complaint is related to the manufacturing process of the unit.A product history record (phr) review of lot 18370302 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) ¿ separated¿ was not observed during the product evaluation.The returned catheter did not present with any damages, and the root cause of the reported event cannot be found.Given that the damages were noted prior to inserting in the patient, handling factors cannot be excluded.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 product labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.To prevent kinking of 5f (1.65 mm) and smaller diagnostic catheters: 1.Straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.2.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi).¿ based on the available information and product analysis, there is no evidence to suggest the event is related to the device design or manufacturing process.Therefore, no preventative or corrective 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: 23553547
• Report Number: 9616099-2025-01837
• Device Sequence Number: 18503813
• Product Code: DQO
• UDI-Device Identifier: 10705032008273
• UDI-Public: (01)10705032008273(17)270831(10)18370302
• 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): 01/13/2026

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: 451503H5
• Device Lot Number: 18370302
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 11/23/2025; 01/09/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/01/2025; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2024
• 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.
• Patient Age: 69 YR
• Patient Sex: Male