MAUDE Adverse Event Report: CORDIS US CORP. AVANTI TRANSRADIAL; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number	504615Z
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, there was a slide of the guidewire of the 5f avanti plus introducer with mini guidewire into the left ventricle during pericardiocentesis.The patient underwent open ventricular septal defect repair; tricuspid valvuloplasty and right ventricular outflow tract unblocking plus guidewire removal for hemostasis and other treatments.Approximately five days prior to the event, the patient underwent ventricular septal defect occlusion.On the day of the event results of a cardiac ultrasound suggested pericardial effusion and mild tricuspid valve closure insufficiency.The device is expected to be returned for evaluation.The hospital reported it as an adverse event to the china nmpa directly.Please upgrade this case to ae.
Additional Manufacturer Narrative
As reported, there was a slide of the guidewire of the 5f avanti plus introducer with mini guidewire into the left ventricle during pericardiocentesis.The patient underwent open ventricular septal defect repair; tricuspid valvuloplasty and right ventricular outflow tract unblocking plus guidewire removal for hemostasis and other treatments.Approximately five days prior to the event, the patient underwent ventricular septal defect occlusion.On the day of the event results of a cardiac ultrasound suggested pericardial effusion and mild tricuspid valve closure insufficiency.Without the return of the device or images for analysis, the reported customer event ¿mini guidewire-fractured-separated¿ could not be confirmed.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, ¿inspect the system contents for any signs of damage; do not use if any damage is present.Do not withdraw the guidewire back though the metal cannula of the needle after it has been inserted as it may damage the guidewire.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.
Event or Problem Description
Multiple attempts to obtain supplemental information were made including the return of the device; however, additional event details and product return information were not provided.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.
Additional Manufacturer Narrative
A product history record (phr) review of lot 18180343 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.

• Brand Name: AVANTI TRANSRADIAL
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18393641
• Report Number: 9616099-2023-06674
• Device Sequence Number: 21013454
• Product Code: DRE
• UDI-Device Identifier: 10705032010276
• UDI-Public: (01)10705032010276(17)261231(10)18180343
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970392
• 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,Followup,Followup
• Report Date (Section B): 08/29/2024

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
• Device Catalogue Number: 504615Z
• Device Lot Number: 18180343
• Was Device Available for Evaluation?: Yes
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 01/11/2024; 08/15/2024; 08/29/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 01/12/2024; 08/15/2024; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2023
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown