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

Catalog Number	451443H0
Medical Device Problem Codes	Crack (1135); Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: phone#: (b)(6).Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the vascular team underwent an evar procedure where they used a cordis 4fr c2 tempo catheter.During the case it was apparent that the catheter tip fractured over the non-cordis wire.There was no reported injury to the patient.The device will be returned for evaluation.
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.
Event or Problem Description
As reported, the vascular team underwent an evar procedure where they used a cordis 4fr c2 tempo catheter.During the case it was apparent that the catheter tip fractured over the non-cordis wire.There was no reported injury to the patient.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.
Event or Problem Description
As reported, the vascular team underwent an evar procedure where they used a cordis 4fr c2 tempo catheter.During the case it was apparent that the catheter tip fractured over the non-cordis wire.There was no reported injury to the patient.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.
Additional Manufacturer Narrative
As reported, the vascular team underwent an evar procedure where they used a cordis 4fr c2 tempo catheter.During the case it was apparent that the catheter tip fractured over the non-cordis wire.There was no reported injury to the patient.Additional information was requested; however, the information was not obtained after multiple attempts.One non-sterile ¿cath tempo 4f c2 100cm¿ unit was received for analysis.During the visual inspection, three kinked/bent sections were seen on the catheter body, found approximately 32.5 cm, 59.0 cm and 93.6 cm from the distal tip.Additionally, one torn condition was noted on the diagnostic catheter body near to the brite tip/ distal tip, found approximately at 2.4 cm from the distal tip.No other anomalies were seen during the visual inspection.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Microscopic examination involved capturing amplified images of the torn condition and kinked/bent sections of the received device.Sem analysis was not performed, as the damage associated with the torn condition was visible at the magnification provided by the vision system.The results showed that the edges of the torn condition exhibited signs of slight elongations and scratches.No other anomalies were observed during the microscopic examination.The complaint reported by the customer as "brite tip/ distal tip- frayed/split/torn" was confirmed.During the visual and microscopic examination evidence of a torn condition was found near to the brite tip.The elongations found on the plastic material of the unit are commonly associated with events where material tensile overload occurred.Therefore, it is assumed that the unit was induced to a tensile force that exceeded the material yield strength prior to the torn condition.Microscopic analysis near the damages revealed scratch marks, which suggests the tear may have been caused by a sharp object such as medical instrument or device component.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 to make 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, there is no indication that 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 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: 20922147
• Report Number: 9616099-2024-00522
• Device Sequence Number: 12025892
• Product Code: DQO
• UDI-Device Identifier: 10705032008044
• UDI-Public: (01)10705032008044(17)250731(10)18139420
• 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): 02/13/2025

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: 07/31/2025
• Device Catalogue Number: 451443H0
• Device Lot Number: 18139420
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/23/2024; 01/27/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/17/2025; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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: LUNDERQUIST WIRE.
• Patient Sex: Unknown