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

Catalog Number	451403H5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, the distal tip of a 4f 100cm 5 side-hole pigtail tempo diagnostic catheter was found cracked inside of the packaging and was not used.A new 4f 100cm 5 side-hole pigtail tempo diagnostic catheter was used as a replacement.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu) and there was no damage to the device packaging.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11 complaint conclusion: as reported, the distal tip of a 4f 100cm 5 side-hole pigtail tempo diagnostic catheter was found cracked inside of the packaging and was not used.A new 4f 100cm 5 side-hole pigtail tempo diagnostic catheter was used as a replacement.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu) and there was no damage to the device packaging.A non-sterile cath tempo 4f pig 100cm 5sh unit was received for analysis.During visual inspection, two kinked or bent sections were identified on the catheter body, located approximately at 77.5 cm and 92.0 cm from the hub.Additionally, the tip-straightener was received separately from the device.No damage was observed at the distal tip of the catheter.Dimensional analysis was performed near the identified damaged regions to verify the outer diameter (od) and inner diameter (id).All measurements were found to be within product specifications.Scanning electron microscopy (sem) was not conducted, as high-magnification visual inspection was sufficient to confirm the integrity of the diagnostic catheter tip.This evaluation verified that the tip was fully intact and undamaged.The reported complaint of ¿brite tip/distal tip ¿ cracked¿ was not confirmed.However, two kinked conditions were observed on the returned catheter body.The exact root cause of the kinks could not be determined.Storage and handling factors are considered possible contributors.Users are instructed to inspect devices for damage prior to and during use, and not to use any product showing signs of damage.Safety information is provided in the product labeling to raise awareness of associated risks.Per the instructions for use (ifu), although not intended as a risk mitigation strategy, users are advised to: ¿store in a cool, dark, dry place.Do not use if package is open or damaged." based on the available information and product analysis, there is no evidence to suggest that the observed condition is related to 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 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: 21592835
• Report Number: 9616099-2025-00384
• Device Sequence Number: 21050104
• Product Code: DQO
• UDI-Device Identifier: 10705032007696
• UDI-Public: (01)10705032007696(17)260831(10)18243560
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 451403H5
• Device Lot Number: 18243560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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: 4F 100CM 5 SH PIGTAIL TEMPO DIAGNOSTIC CATHETER
• Patient Sex: Unknown