MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F UF 65CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451404V5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During use in the patient of the tempo diagnostic universal flush (uf) catheter, the catheter almost separated and the wire came out the side.There was no patient injury.Another tempo catheter was used to complete the procedure.The target lesion is the iliac bifurcation which is mildly tortuous and calcified.The device was handled according to the instruction for use (ifu).There were no difficulties removing the product from the packaging.There was no resistance with advancing or withdrawing the catheter.There were no excessive force used anytime during the procedure.The device is available for analysis.
Additional Manufacturer Narrative
This device was received for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
During use in the patient of the tempo diagnostic universal flush (uf) catheter, the catheter almost separated and the wire came out the side.There was no patient injury.Another tempo catheter was used to complete the procedure.The target lesion is the iliac bifurcation which is mildly tortuous and calcified.The device was handled according to the instruction for use (ifu).There were no difficulties removing the product from the packaging.There was no resistance with advancing or withdrawing the catheter.There were no excessive force used anytime during the procedure.The device is available for analysis.
Additional Manufacturer Narrative
This device was received for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
During use in the patient of the tempo diagnostic universal flush (uf) catheter, the catheter almost separated, and the wire came out the side.There was no patient injury.Another tempo catheter was used to complete the procedure.The target lesion is the iliac bifurcation which is mildly tortuous and calcified.The device was handled according to the instruction for use (ifu).There were no difficulties removing the product from the packaging.There was no resistance with advancing or withdrawing the catheter.There was no excessive force used anytime during the procedure.One non-sterile cath tempo 4f uf 65cm 5sh unit was received for analysis.No anomalies were observed during visual inspection.Functional analysis was performed by completing a flushing test and no leaks, difficulty or anomalies were noted on the unit.A product history record (phr) review of lot 18053427 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported customer event ¿catheter (body/shaft)-cracked in-patient¿ could not be confirmed as this condition was not observed during analysis.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 open or damaged packages.Exposure to temperatures above 54°c (130°f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and gently withdraw the catheter.¿ based on the information available and the phr review, 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: CATH TEMPO 4F UF 65CM 5SH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13404316
• Report Number: 9616099-2022-05323
• Device Sequence Number: 4935363
• Product Code: DQO
• UDI-Device Identifier: 10705032007733
• UDI-Public: 10705032007733
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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: 08/31/2024
• Device Model Number: 451404V5
• Device Catalogue Number: 451404V5
• Device Lot Number: 18053427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• 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 TEMPO CATHETER
• Patient Sex: Unknown