MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SI AVANTI+ 7F STD W/GW NO OBT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	504607X
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	10/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be sent in upon 30 days after receipt.
Event or Problem Description
As reported, while the physician was pulling out a 7f standard (std) with guidewire (w/gw) no obturator (obt) avanti plus catheter sheath introducer; the sheath broke.They had to snare the part of the sheath that was left in the patient which was detached when the sheath was pulled out.The user was trained with the device.The device was opened in a sterile field.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections d8, d9, g3, g6, h2 and h3 have been updated accordingly.The device has been returned for evaluation, but the manufacture report is not yet available.Additional information is pending and will be sent in upon 30 days after receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6 and h2 have been updated accordingly.As reported, while the physician was pulling out a 7f standard (std) with guidewire (w/gw) no obturator (obt) avanti plus catheter sheath introducer; the sheath broke.They had to snare the part of the sheath that was left in the patient which was detached when the sheath was pulled out.The user was trained with the device.The device was opened in a sterile field.Additional procedural details were requested but are unknown.The product was returned for analysis.One non-sterile unit of catheter si avanti+ 7f std w/gw no obt was received inside of a clear plastic bag.Per visual analysis, only a portion of a separated cannula was returned for analysis, amplified images of the damage were taken.No other damages or anomalies were observed on the component returned.Amplified images of the separated condition were taken in order to determine the characteristics of the damage.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 plastic yield strength prior to the separation.A product history record (phr) review of lot 17938061 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter sheath introducer (csi) - separated - in patient¿ confirmed during the analysis of the returned device.The exact cause of the reported event could not be conclusively determined.The edge of the separated area presented evidence of elongations and frayed edges.These characteristics suggest that the device was induced to stretching/pulling or twisting events that exceed the material yield strength prior to the separation.Procedural or handling factors might have contributed to this issue.According to the instructions for use (ifu) which is not intended as a mitigation of risk, users are cautioned that if increased resistance is felt upon insertion or withdrawal 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.Neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken at this time.Complaint conclusion has been updated as the lot number and catalog is known.
Additional Manufacturer Narrative
As reported, while the physician was pulling out a 7f standard (std) with guidewire (w/gw) no obturator (obt) avanti plus catheter sheath introducer; the sheath broke.They had to snare the part of the sheath that was left in the patient which was detached when the sheath was pulled out.The user was trained with the device.The device was opened in a sterile field.Additional procedural details were requested but are unknown.The product was returned for analysis.One non-sterile unit of catheter si avanti+ 7f std w/gw no obt was received inside of a clear plastic bag.Per visual analysis, only a portion of a separated cannula was returned for analysis, amplified images of the damage were taken.No other damages or anomalies were observed on the component returned.Amplified images of the separated condition were taken in order to determine the characteristics of the damage.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 plastic yield strength prior to the separation.A product history record (phr) review of lot 17938061 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter sheath introducer (csi) - separated - in patient¿ confirmed during the analysis of the returned device.The exact cause of the reported event could not be conclusively determined.The edge of the separated area presented evidence of elongations and frayed edges.These characteristics suggest that the device was induced to stretching/pulling or twisting events that exceed the material yield strength prior to the separation.Procedural or handling factors might have contributed to this issue.According to the instructions for use (ifu) which is not intended as a mitigation of risk, users are cautioned that if increased resistance is felt upon insertion or withdrawal 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 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+ 7F STD W/GW NO OBT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 10904896
• Report Number: 9616099-2020-04085
• Device Sequence Number: 2465377
• Product Code: DRE
• UDI-Device Identifier: 20705032010105
• UDI-Public: 20705032010105
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/05/2021

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 Expiration Date: 02/28/2023
• Device Model Number: 504607X
• Device Catalogue Number: 504607X
• Device Lot Number: 17938061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/03/2020; 01/05/2021; 01/05/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/28/2020; 01/05/2021; 01/05/2021
• 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.