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

Catalog Number	451406P0
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
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.
Event or Problem Description
As reported, the inner pouch packaging of a 4f multi-purpose a1 (i) 125cm tempo diagnostic catheter was damaged.The sterile pouch was received open/compromised.The product was unused.It is not possible that the product had been purposely opened in anticipation of use and then reshelved.The condition was noted after it had been received and stored in the lab prior to use.In the lab, it was stored in the cath lab and managed by a specialist.The actual product was not damaged.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the inner pouch packaging of a 4f multi-purpose a1 (i) 125cm tempo diagnostic catheter was damaged.The sterile pouch was received open/compromised.The product was unused.It is not possible that the product had been purposely opened in anticipation of use and then reshelved.The condition was noted after it had been received and stored in the lab prior to use.In the lab, it was stored in the cath lab and managed by a specialist.The actual product was not damaged.One image was provided for review an no anomalies or outstanding details could be observed.A non-sterile cath tempo 4f mp a1 (i) 125cm 100cm was subsequently received for analysis inside a plastic bag.During visual analysis, the pouch was noted to be completely clean and sealed.Dimensional analysis was not required because no compressions or other type of abnormal conditions were observed on the received unit.The reported event ¿packaging/pouch/box - compromised sterility - seal open¿ was not confirmed because the device that was returned did not present with any evidence of compromised sterility.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: 20619758
• Report Number: 9616099-2024-00366
• Device Sequence Number: 12966909
• Product Code: DQO
• UDI-Device Identifier: 10705032007757
• UDI-Public: (01)10705032007757(17)261031(10)18262913
• 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
• Report Date (Section B): 11/26/2024

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: 451406P0
• Device Lot Number: 18262913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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
• Patient Sex: Unknown