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

Catalog Number	451506H0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, while establishing a track for the delivery of an unknown patent ductus arteriosus (pda) occluder with a 5f 100cm multipurpose (mpa) tempo diagnostic catheter, the patient¿s heart rate dropped to 30 beats per minute, and oxygenation dropped to unmeasurable levels.A bedside cardiac ultrasound was performed and revealed a pericardial effusion.The device was removed and a pericardiocentesis was performed.Bloody fluid was extracted, and the patient was observed; however, the effusion continued to gradually increase after the extraction of fluid.The patient¿s heart rate and oxygen levels returned to normal, but due to the pericardial effusion continuing to increase, emergency cardiac surgery was performed.The surgical procedure was successful, and the patient was discharged after the surgery.The tempo catheter was used to deliver the unknown pda occluder.There was no difficulty placing the unknown pda occluder through the 5f tempo catheter.The device was discarded and will not be returned.The hospital reported it as an adverse event to the china nmpa directly.
Additional Manufacturer Narrative
Complaint conclusion: as reported, while establishing a track for the delivery of an unknown patent ductus arteriosus (pda) occluder with a 5f 100cm multipurpose (mpa) tempo diagnostic catheter, the patient¿s heart rate dropped to 30 beats per minute, and oxygenation dropped to unmeasurable levels.A bedside cardiac ultrasound was performed and revealed a pericardial effusion.The device was removed and a pericardiocentesis was performed.Bloody fluid was extracted, and the patient was observed; however, the effusion continued to gradually increase after the extraction of fluid.The patient¿s heart rate and oxygen levels returned to normal, but due to the pericardial effusion continuing to increase, emergency cardiac surgery was performed.The surgical procedure was successful, and the patient was discharged after the surgery.The tempo catheter was used to deliver the unknown pda occluder.There was no difficulty placing the unknown pda occluder through the 5f tempo catheter.The device was discarded and therefore, could not be returned.Without the return of the device or images for analysis, it cannot be confirmed if the reported customer event ¿pericardial effusion¿ is related to the tempo diagnostic catheter.Procedural/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 damaged.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ 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.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• 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: 19392472
• Report Number: 9616099-2024-00170
• Device Sequence Number: 6945874
• Product Code: DQO
• UDI-Device Identifier: 10705032008334
• UDI-Public: (01)10705032008334(17)261031(10)18256722
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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
• Device Catalogue Number: 451506H0
• Device Lot Number: 18256722
• 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: 05/09/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2023
• 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 PDA DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 MO
• Patient Sex: Female
• Patient Weight: 8 KG