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

Catalog Number	402607X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, upon removal from the patient, the 7f 11 cm avanti plus sheath introducer with mini-guidewire was noted broken.One part of the catheter stayed in the patient's right hand and the tip stayed in the patient.The physician was successful in removing the distal part from the patient.The 7f sheath was being used for an atrial fibrillation ablation procedure for a quadripolar non-cordis lead for femoral venous access.A picture was received for review.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
As reported, upon removal from the patient, the 7f 11 cm avanti plus sheath introducer with mini-guidewire was noted broken (separated).One part of the catheter stayed in the patient's right hand and the tip stayed in the patient.The physician was successful in removing the distal part from the patient.The 7f sheath was being used for an atrial fibrillation ablation procedure for a quadripolar non-cordis lead for femoral venous access.There were no anomalies noted when the product was removed from the package.The device was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device, and no resistance or friction was encountered during the procedure.No unusual force or excessive torquing was required.The patient was not hospitalized due to the event.No procedural cd or films are available for review.The device was not returned as anticipated.One image was submitted for review and it shows a 7f avanti csi with separated cannula.The separation is near the hub.The guidewire remained on the distal separated portion.No other anomalies nor outstanding details could be observed on the images provided.The reported ¿catheter sheath introducer (csi) - separated¿ was confirmed since a separated condition was noted on the cannula of the unit.However, without performing a product evaluation, the root cause cannot be determined.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 increased resistance is felt upon insertion of the csi, or an intravascular device through the csi, investigate the cause before continuing.If the cause cannot be determined and corrected, discontinue the procedure and withdraw the csi.¿ 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
The device was not returned as anticipated.

• Brand Name: AVANTI
• 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: 20684657
• Report Number: 9616099-2024-00392
• Device Sequence Number: 8659066
• Product Code: DRE
• UDI-Device Identifier: 10705032000673
• UDI-Public: (01)10705032000673(17)270731(10)18354454
• 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): 12/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 402607X
• Device Lot Number: 18354454
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2024
• 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: AF ABLATION.
• Patient Sex: Unknown