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

Catalog Number	504608X
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the tip of an 8f avanti sheath catheter sheath introducer (csi) was split during the puncture because the tip end of the sheath was too soft.The surgeon replaced the issue product with a new one.The new sheath had the same problem too.Then the surgeon replaced it with another one and the third one was used normally.Three sheaths from the same catalog were used in the procedure.The vessel dilator was not snapped into place at the hub.There was no issue snapping the dilator into place.No physical injury was caused to the patient, but it caused distress to the operator.The device was stored and prepped according to the ifu.A contralateral approach was used.The access site was not tortuous and had no calcium.The device was flushed prior to use.The access site was pre dilated.The patient was transferred to the department from the catheterization laboratory with a diagnosis of acute myocardial infarction.Due to critical condition, the aortic balloon catheter was punctured.The aortic balloon counterbore was connected immediately and the procedure was successful.The hospital reported it as an adverse event to the china nmpa directly.The device is being returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18186278 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
The report is related to medwatch# 9616099 -2023-06562.As reported, the tip of an 8f avanti sheath catheter sheath introducer (csi) was split during the puncture because the tip end of the sheath was too soft.The surgeon replaced the issue product with a new one.The new sheath had the same problem too.Then the surgeon replaced it with another one and the third one was used normally.Three sheaths from the same catalog were used in the procedure.The vessel dilator was not snapped into place at the hub.There was no issue snapping the dilator into place.No physical injury was caused to the patient, but it caused distress to the operator.The device was stored and prepped according to the ifu.A contralateral approach was used.The access site was not tortuous and had no calcium.The device was flushed prior to use.The access site was pre dilated.The patient was transferred to the department from the catheterization laboratory with a diagnosis of acute myocardial infarction.Due to critical condition, the aortic balloon catheter was punctured.The aortic balloon counterbore was connected immediately and the procedure was successful.The products were not returned for analysis.Two non-cordis devices were returned instead.Both lot numbers for the reported avanti csi devices share the same lot number.A product history record (phr) review of lot 18186278 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the devices or images for analysis, the reported customer event ¿brite tip/distal tip-frayed/split/torn¿ could not be confirmed for either device.Failure to snap the dilator into the hub inhibited a smooth transition during the csi insertion.This likely placed undue stress on the distal tip, which lead to the reported damages.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, ¿insert the vessel dilator through the csi¿s hemostasis valve, snapping it into place at the hub.Thread the csi/dilator assembly over the guidewire, grasping the sheath close to the skin to prevent buckling.Using a rotating motion, advance the assembly through the tissue and into the vessel.¿ based on the information available and the phr review, 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.H3 other text : devices returned found to be non-cordis devices.

• Brand Name: AVANTI
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 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: 17423860
• Report Number: 9616099-2023-06561
• Device Sequence Number: 12655250
• Product Code: DRE
• UDI-Device Identifier: 10705032010153
• UDI-Public: (01)10705032010153(17)260131(10)18186278
• 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
• Report Date (Section B): 10/30/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 504608X
• Device Lot Number: 18186278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2023
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 55 KG