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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 5f simmons (sim) 1 100cm tempo diagnostic catheter fractured during use, with a portion of the catheter breaking inside the body.The broken catheter was removed using a snare, causing the procedure time to be extended.The distal tip of the device separated, and no anomalies were noted when it was removed from the package or during preparation.No resistance was encountered while advancing the device, no excessive torqueing was required, and no resistance occurred while advancing the device over the guidewire.The device did not kink in the area of separation, and no resistance was met during withdrawal.The device was not used for a chronic total occlusion, was not resterilized, and the patient¿s current status is good.There were no obvious signs of device or packaging damage prior to use.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.Complaint conclusion: as reported, a 5f simmons (sim) 1 100cm tempo diagnostic catheter fractured during use, with a portion of the catheter breaking inside the body.The broken catheter was removed using a snare, causing the procedure time to be extended.The distal tip of the device separated, and no anomalies were noted when it was removed from the package or during preparation.No resistance was encountered while advancing the device, no excessive torquing was required, and no resistance occurred while advancing the device over the guidewire.The device did not kink in the area of separation, and no resistance was met during withdrawal.The device was not used for a chronic total occlusion, was not resterilized, and the patient¿s current status is good.There were no obvious signs of device or packaging damage prior to use.The cath tempo 5f sim 1 100cm device was returned non-sterile for evaluation and was found to exhibit separation, with the hub and distal end not received; visual inspection also identified multiple kinked and bent sections along the catheter body.Dimensional assessment was performed near the separation regions and representative kinked/bent areas, and all measurements were confirmed to be within specification.Microscopic evaluation of the separation interface identified plastic deformation, multiple material elongations, a localized scratch, and exposed wire.These findings are consistent with mechanical stress such as excessive bending, tensile loading, or contact with another surface, with elongation patterns indicative of tensile overload leading to separation; overall, there is no evidence to suggest the failure is related to manufacturing or design processes.The reported ¿catheter (body/shaft) ¿ separated¿ was observed.The exact cause of the separation cannot be determined.Evaluation results revealed multiple kinked sections and signs of tensile overload; therefore, use related factors cannot be excluded.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 of making the user aware of the risks.According to the instructions for use (ifu), ¿this product is intended for use by professionals who have been trained to perform coronary diagnostic and interventional procedures.¿ based on the available information, there is no evidence to suggest the reported event is related to manufacturing or design issues.Therefore, no additional actions will be taken.

• 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: 24489907
• Report Number: 9616099-2026-00332
• Device Sequence Number: 5092411
• Product Code: DQO
• UDI-Device Identifier: 10705032008563
• UDI-Public: (01)10705032008563(17)280731(10)18489579
• 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): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 451530H0
• Device Lot Number: 18489579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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: AVANTI+ 5F 11CM.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian