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

Catalog Number	504505X
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
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, after insertion into the patient a 5f.038¿ vessel dilator had to be removed as there was an incomplete connection at the valve.There was no reported patient injury.Resistance was felt proximal at the side arm/valve when threading the wire.After insertion into the patient, a ¿paraluminate¿ was noticed here.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
Additional information received revealed the event involves a leak.Based on the additional information, the event is non-reportable.The malfunction reported is not likely to cause or contribute to a death or serious upon recur.Therefore, no additional regulatory reports are required.
Event or Problem Description
As reported, after insertion into the patient a 5f.038¿ vessel dilator had to be removed as there was an incomplete connection at the valve.There was no reported patient injury.Resistance was felt proximal at the side arm/valve when threading the wire.After insertion into the patient, a ¿paraluminate¿ (water leaked out next to the lock connection part).There was simply a valve leak.The intended procedure was reported to be a percutaneous transluminal angioplasty (pta) for which a contralateral approach was not used.The device was not pulled from the packaging by the hub.The product was stored, handled, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.The vessel dilator snapped into place at the hub.There were no difficulties encountered during the insertion process or during the withdrawal process.There was no excess force used during the procedure.Only when the wire was threaded through did a resistance become apparent.

• Brand Name: VESSEL DILATOR
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 19537882
• Report Number: 9616099-2024-00198
• Device Sequence Number: 8412472
• Product Code: DRE
• UDI-Device Identifier: 10705032009836
• UDI-Public: 10705032009836
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/02/2024

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: 504505X
• Device Lot Number: 18299969
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2024
• 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 WIRE
• Patient Sex: Unknown