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

Catalog Number	451503H5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, when the 5f pigtail 100cm 5-sidehole (sh) tempo diagnostic catheter was taken out of the package, the catheter separated into two parts.There was no reported patient injury, as the device was not used in the patient.It was stored correctly like all the products that are always used in this hospital, with no damages found on the device packaging prior to opening.The device was stored where all medical products are stored, in a warehouse with access control via password.The reported ¿catheter (body/shaft) separated¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined however, handling and storage factors could have led to the reported event.The instructions for use (ifu) cautions users to inspect for any signs of damage prior to and during use.The ifu instructs any product with damage to not be used.The information available does not suggest a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
Event or Problem Description
As reported, when the 5f pigtail 100cm 5-sidehole (sh) tempo diagnostic catheter was taken out of the package, the catheter separated into two parts.There was no reported patient injury, as the device was not used in the patient.It was stored correctly like all the products that are always used in this hospital, with no damages found on the device packaging prior to opening.The device was stored where all medical products are stored, in a warehouse with access control via password.No photos of the device were available as they were discarded.The device will not be returned for evaluation.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14021 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 20684022
• Report Number: 9616099-2024-00390
• Device Sequence Number: 15262529
• Product Code: DQO
• UDI-Device Identifier: 10705032008273
• UDI-Public: (01)10705032008273(17)260630(10)18223018
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 451503H5
• Device Lot Number: 18223018
• 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: 10/31/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown