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

Catalog Number	504607T
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
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 per account, the unknown biopsy forceps went through 7fr avanti + catheter sheath introducer (csi) wall while in the patient.The patient had to be admitted with further imaging/treatment done.Heart biopsy procedure was being attempted via right jugular vein access.The device was used as intended.There were no unusual circumstances with patient or procedure/surgery.The device was not expired or damaged.The device was no misused in any way.An unknown 0.035" 3mm j-tip 145cm wire was used during the procedure.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the unknown biopsy forceps went through 7fr avanti + catheter sheath introducer (csi) wall while in the patient.The patient had to be admitted with further imaging/treatment done.Heart biopsy procedure was being attempted via right jugular vein access.The device was used as intended.There were no unusual circumstances with patient or procedure/surgery.The device was not expired or damaged.The device was no misused in any way.An unknown 0.035" 3mm j-tip 145cm wire was used during the procedure.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the unknown biopsy forceps went through 7fr avanti + catheter sheath introducer (csi) wall while in the patient.The patient had to be admitted with further imaging/treatment done.Heart biopsy procedure was being attempted via right jugular vein access.The device was used as intended.There were no unusual circumstances with patient or procedure/surgery.The device was not expired or damaged.The device was not misused in any way.An unknown 0.035" 3mm j-tip 145cm wire was used during the procedure.A non-sterile si avanti+ 7f mid w/o gw&obt was received in a clear plastic bag along with a biopsy forceps device.Only the introducer was returned for analysis, with the biopsy forceps device inserted into the cannula.Inspection revealed a puncture on the cannula approximately 13 cm from the distal tip.The damage exhibited elongations and fatigue lines, indicating it originated from the inside out.These features suggest the cannula was subjected to a tensile force by an unknown sharp object that exceeded the material¿s yield strength.No other anomalies were observed.The reported customer event ¿cannula-puncture/cut¿ was observed during the product analysis.It is assumed that the device was induced to a tensile force that exceeded the material yield strength prior to the puncture.An interaction between the cannula and biopsy forceps is the likely root cause.Based on the available information, it cannot be determined if the required ¿hospitalization¿ was related to the damaged device.No injuries were reported and there were no unusual circumstances with patient or procedure/surgery.Therefore, it¿s possible the reported admission may have been related to the patient¿s diagnosis.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, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the csi.Hold the sheath in place when inserting, positioning, or removing the catheter.¿ based on the available information and product analysis, there is no evidence to suggest 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 unknown biopsy forceps went through 7fr avanti + catheter sheath introducer (csi) wall while in the patient.The patient had to be admitted with further imaging/treatment done.Heart biopsy procedure was being attempted via right jugular vein access.The device was used as intended.There were no unusual circumstances with patient or procedure/surgery.The device was not expired or damaged.The device was no misused in any way.An unknown 0.035" 3mm j-tip 145cm wire was used during the procedure.The device will be returned for evaluation.

• Brand Name: AVANTI
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 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: 21459252
• Report Number: 9616099-2025-00303
• Device Sequence Number: 7986932
• Product Code: DRE
• UDI-Device Identifier: 10705032010085
• UDI-Public: (01)10705032010085(17)270131(10)18283811
• 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
• Report Date (Section B): 05/14/2025

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?: No
• Device Catalogue Number: 504607T
• Device Lot Number: 18283811
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 03/06/2025; 04/22/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/30/2025; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other
• Patient Age: 36 YR
• Patient Sex: Male