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

Catalog Number	451543V0
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, by the purchasing department, a 5f 65cm tempo diagnostic catheter was used in a patient and the product "broke".The damage was described as frayed, split torn during use in the patient.The device broke off at the base during rotation of the catheter after a few attempts, trying to steer the catheter.Another product with the same lot was taken and it broke again.A third product was then taken which did not break.There was no reported patient injury.The intended procedure was reported as iliac- side branch, probing of the vessel of the left internal carotid artery (ica).The product was stored and handled according to the instructions for use (ifu).There was no device damage noticed prior to opening the package or difficulty removing the device from the sterile packaging.There was severe lesion calcification and tortuosity.The devices were discarded and will not be returned.
Additional Manufacturer Narrative
As reported, by the purchasing department, a 5f 65cm tempo diagnostic catheter was used in a patient and the product "broke".The damage was described as frayed, split torn during use in the patient.The device broke off at the base during rotation of the catheter after a few attempts, trying to steer the catheter.Another product with the same lot was taken and it broke again.A third product was then taken which did not break.There was no reported patient injury.The intended procedure was reported as iliac- side branch, probing of the vessel of the left internal carotid artery (ica).The product was stored and handled according to the instructions for use (ifu).There was no device damage noticed prior to opening the package or difficulty removing the device from the sterile packaging.There was severe lesion calcification and tortuosity.The devices were discarded and will not be returned.Without the return of the devices or images for analysis, the reported customer event ¿brite tip/distal tip-frayed/split/torn¿ could not be confirmed for either device.Procedural or handling factors may have contributed to the reported event.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, ¿do not use if package is open or damaged.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 19684967
• Report Number: 9616099-2024-00224
• Device Sequence Number: 16916573
• Product Code: DQO
• UDI-Device Identifier: 10705032008679
• UDI-Public: (01)10705032008679(17)270131(10)18289859
• 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): 08/28/2024

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: 451543V0
• Device Lot Number: 18289859
• Was Device Available for Evaluation?: No
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 08/28/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 07/15/2024; 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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: CATH TEMPO 5F C2 65CM
• Patient Sex: Unknown