MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F C2 65CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451443V0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was conducted, and the product met quality requirements for product acceptance.This 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
During prep, the hub of the tempo catheter was damaged (cracked) when the catheter was unpacked.There was no patient injury.Another unknown catheter was used to complete the procedure.There was no damages noted to the packaging.The catheter was handled according to the instruction for use (ifu) with no force needed.The device will be returned for analysis.
Additional Manufacturer Narrative
During prep, the hub of the tempo catheter was damaged (cracked) when the catheter was unpacked.There was no patient injury.Another unknown catheter was used to complete the procedure.There were no damages noted to the packaging.The catheter was handled according to the instruction for use (ifu) with no force needed.The products were not returned for analysis.A product history record (phr) review of lot 18038752 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿luer hub- cracked-during prep¿ could not be confirmed.Shipping, storage 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, ¿store in a cool, dark, dry place.Do not use if package is open or damage¿ 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 C2 65CM
• 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: 14107548
• Report Number: 9616099-2022-05543
• Device Sequence Number: 4789367
• Product Code: DQO
• UDI-Device Identifier: 10705032008051
• UDI-Public: 10705032008051
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2022

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: 06/30/2024
• Device Model Number: 451443V0
• Device Catalogue Number: 451443V0
• Device Lot Number: 18038752
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 06/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2021
• 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
• Patient Sex: Unknown