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

Catalog Number	SRD5559
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 5f 125 cm tempo diagnostic catheter broke off at the hub during extraction from the sheath.The separated segment was broken off in the patient¿s body but was successfully retrieved.There were no reported injuries to the patient.Additional information was requested but was not provided.The device was not returned.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, a 5f 125 cm tempo diagnostic catheter broke off at the hub during extraction from the sheath.The separated segment was broken off in the patient¿s body but was successfully retrieved.There were no reported injuries to the patient.Additional information was requested but was not provided.The device was not returned.A product history record (phr) review of lot 18357237 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported catheter (body/shaft): separated could not be substantiated because the device was not returned, images were not provided, and insufficient event details were available; therefore, the exact cause of the reported event cannot be determined.A product history record phr review revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Because the cause of the reported event could not be determined from the available information, a case-specific assessment of residual risk communication could not be performed.Based on the available information, there is no evidence to suggest the reported event is related to manufacturing or design issues.

• 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: 24532053
• Report Number: 9616099-2026-00344
• Device Sequence Number: 9026902
• Product Code: DQO
• UDI-Device Identifier: 10705032048545
• UDI-Public: (01)10705032048545(17)270731(10)18357237
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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
• Device Catalogue Number: SRD5559
• Device Lot Number: 18357237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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: UNKNOWN.
• Patient Sex: Unknown