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

Catalog Number	504605X
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	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, after insertion, the hub on a 5f avanti sheath introducer popped off, and while putting the cap back on, the cap split.There were no reports of patient injury.The device will be returned for evaluation.
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: b5, g3, g6, h2, h3, h6, and h10.Complaint conclusion: as reported, after insertion, the hub on a 5f avanti sheath introducer popped off, then the cap split while putting it back on.There were no reports of patient injury.The device was not returned for evaluation.One picture related to the reported malfunction on product ¿avanti + 5f std w/gw¿ was attached in this complaint file.In the picture a cordis csi french 5 is observed inside a clear plastic bag with the vessel dilator of the appropriate french size partially inserted into the cannula through the cap.Presence of blood inside the bag was noticed.The cap ring presents with a cracked condition.No other outstanding details were observed in the attached pictures.The complaint reported by the customer as ¿hemostasis valve/hub ~ separated¿ was not confirmed.The received picture does not show a separation to the hemostasis valve.However, the complaint reported by the customer as ¿hemostasis valve/hub~ cracked¿ was confirmed, a cracked condition was observed on the cap ring.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, ¿detach the vessel dilator from the csi by releasing the snap fit ring at the hub.¿ 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.
Event or Problem Description
As reported, after insertion, the hub on a 5f avanti sheath introducer popped off, and while putting the cap back on, the cap split.There were no reports of patient injury.The device was not returned for evaluation.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: AVANTI
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS US CORP; 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 ; 7863138372
• MDR Report Key: 19382429
• Report Number: 9616099-2024-00168
• Device Sequence Number: 6499950
• Product Code: DRE
• UDI-Device Identifier: 10705032009980
• UDI-Public: (01)10705032009980(17)270331(10)18304827
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 504605X
• Device Lot Number: 18304827
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 06/12/2024; 08/27/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/19/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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 SHEATH
• Patient Sex: Unknown