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

Catalog Number	504606X
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, the guidewire of an 6f 11cm avanti + sheath introducer did not enter smoothly into the needle that had entered the blood vessel, then the operator pulled out the wire.When the wire came out, the condition of the wire was damaged.There were no reports of patient injury.The patient was undergoing a coronary artery bypass graft (cabg).One image was submitted for analysis.During visual inspection, an unraveled mini guidewire placed inside a plastic bag was noted.The reported "mini guidewire-resistance/friction¿ cannot be confirmed by photo analysis.However, the failure "mini guidewire- unraveled/stretched" was confirmed during the photo analysis.The root cause of the resistance/friction and the unraveled condition could not be conclusively determined as part of the picture evaluation.Withdrawing the mini guidewire from the needle after insertion is a possible cause of the unraveling.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, ¿: if a needle with a metal cannula is used, do not withdraw the guidewire 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 preventative or corrective actions will be taken at this time.
Event or Problem Description
As reported, the guidewire of an 6f 11cm avanti + sheath introducer did not enter smoothly into the needle that had entered the blood vessel.Then the operator pulled out the wire.When the wire came out, the condition of the wire was damaged.There were no reports of patient injury.The patient was undergoing a coronary artery bypass graft (cabg).The device will not be returned for evaluation.Addendum: per the picture analysis, the mini guidewire was unraveled.
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.; 14201 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: 18536911
• Report Number: 9616099-2024-00023
• Device Sequence Number: 7558254
• Product Code: DRE
• UDI-Device Identifier: 10705032010054
• UDI-Public: (01)10705032010054(17)250930(10)18156934
• 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
• Report Date (Section B): 08/14/2024

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 504606X
• Device Lot Number: 18156934
• 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: 01/10/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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
• Patient Sex: Unknown