MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI+ 6F STD W/GW NO OBT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	504606X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review could not be conducted as the sterile lot number was not provided.This device was received for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, 6f avanti plus standard (std) with guidewire (w/gw) no obturator (obt) catheter sheath introducer (csi) was broken and the part of it was still in the groin.A vascular surgery took the patient for exploration and the fragment of retained 10 cm segment of the antegrade arterial sheath was removed at the right popliteal artery.The catheter segment was able to be removed without any further issues.The patient's groins were prepped and draped.After the extracorporeal membrane oxygenation (ecmo) was decannulated, the venous cannula was removed, and pressure was applied.The distal perfusion cannula was removed, followed by the arterial cannula.All cannulas were clamped as the surgeon attempted to remove the distal perfusion cannula.The segment of the removed fragment of the sheath had one end which was tapered and the other end which was jagged consistent with the broken end of the sheath.There were no additional fragments visualized.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
As reported, a 6f avanti plus standard (std) with guidewire (w/gw) no obturator (obt) catheter sheath introducer (csi) was broken and the part of it was still in the groin.A vascular surgery took the patient for exploration and the fragment of retained 10 cm segment of the antegrade arterial sheath was removed at the right popliteal artery.The catheter segment was able to be removed without any further issues.The patient's groins were prepped and draped.After the extracorporeal membrane oxygenation (ecmo) was decannulated, the venous cannula was removed, and pressure was applied.The distal perfusion cannula was removed, followed by the arterial cannula.All cannulas were clamped as the surgeon attempted to remove the distal perfusion cannula.The segment of the removed fragment of the sheath had one end which was tapered and the other end which was jagged consistent with the broken end of the sheath.There were no additional fragments visualized.The product was returned for analysis.One non-sterile unit of catheter si avanti+ 6f std w/gw no obt was received inside of a clear plastic bag.Per visual analysis, the cannula was found separated, only the portion attached to the hub was returned for evaluation.No other damages or anomalies were observed.Per sem analysis, results showed the separated area of the cannula of the si avanti+ 6f std unit presented evidence of elongations.No other anomalies were observed.The elongations found on the cannula material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the cannula material was induced to a tensile force that exceeded the cannula material yield strength prior to the separation.No other anomalies were observed during sem analysis.Product history review could not be performed since complaint lot is unknown.The reported "cannula ¿ separated - in patient¿ was confirmed during analysis of the returned device.The exact cause of the reported event could not be conclusively determined.Handling factors, such as excessive force used, may have contributed to the reported event.Sem results showed the cannula material was induced to a tensile force that exceeded the cannula material yield strength prior to the separation.According to the product instructions for use which is not intended as a mitigation of risk, users are cautioned that 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 as was done in this case.As no lot number, catalogue code or other product information was supplied a phr could not be completed.The information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SI AVANTI+ 6F STD W/GW NO OBT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 10153362
• Report Number: 9616099-2020-03745
• Device Sequence Number: 2318254
• Product Code: DRE
• UDI-Device Identifier: 20705032010051
• UDI-Public: 20705032010051
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K970392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

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
• Operator of Device: Health Professional
• Device Model Number: 504606X
• Device Catalogue Number: 504606X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Weight: 78