MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
When assembling a 6f standard (std) with guidewire (w/gw) no obturator (obt) avanti plus catheter sheath introducer, it was found that the head-end of the catheter was separated.There was no reported patient injury.The device was exchanged for another unknown device and the procedure was completed.The device package was not damaged in any way.There was no difficulty removing the device from the package.The product was stored, handled, inspected and prepped according to the instruction for use (ifu) with nothing unusual noted about the sheath prior to use.The device will be returned for evaluation.There was no adverse event with this reported issue, however, the hospital has chosen to report this as an adverse event to the national medical product administration (nmpa) directly.No other information was provided.
Additional Manufacturer Narrative
When assembling a 6f standard (std) with guidewire (w/gw) no obturator (obt) avanti plus catheter sheath introducer (csi), it was found that the head-end of the catheter was separated.During product analysis, the cap was separated from the hub.The device was exchanged for another unknown device and the procedure was completed.The device package was not damaged in any way.There was no difficulty removing the device from the package.The product was stored, handled, inspected and prepped according to the instructions for use (ifu) with nothing unusual noted about the sheath prior to use.There was no adverse event with this reported issue, however, the hospital has chosen to report this as an adverse event to the national medical product administration (nmpa) directly.There was not reported patient injury.The product was returned for analysis.Per visual analysis, one non-sterile unit of a catheter sheath introducer si avanti+ 6f std w/gw no obt was received inside a clear plastic bag.The cap was found to be separated from the hub.No other anomalies were observed.Per microscopic analysis, the brim cap and hub presented each a lump/bump on their rim surface.The lumps/bumps are from the same brim cap and hub material.No damages or marks were observed surrounding the lumps/bumps.It is assumed by these findings, that the observed lumps/bumps were not caused by the interaction of the brim cap/hub with a sharp object or tool since no damages or marks were observed surrounding the lumps/bumps.Nevertheless, the exact cause of the observed lumps/bumps on the brim cap and hub could not be conclusively determined during this analysis.No other anomalies were observed during the analysis.A product history record (phr) review of lot 17933934 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip-separated-during prep and hemostasis valve/hub~separated - during prep¿ were confirmed by analysis.The exact cause of the reported event could not be conclusively determined.Procedural/handling factors, may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, ¿do not use if package is open or damaged.1.Remove csi from package using sterile technique.2.Remove air from csi by flushing with heparinized saline or suitable isotonic solution.3.Insert the vessel dilator through the csi¿s hemostasis valve, snapping it into place at the hub.Flush with heparinized saline or suitable isotonic solution.¿ neither the phr nor the product analysis available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Additional Manufacturer Narrative
This report was generated in error and due to the system's limitation, a report needed to be submitted.

• Brand Name: SI AVANTI+ 6F 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: 11298363
• Report Number: 9616099-2021-04246
• Device Sequence Number: 12020980
• Product Code: DRE
• UDI-Device Identifier: 10705032010054
• UDI-Public: 10705032010054
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2021

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: 01/31/2023
• Device Model Number: 504606X
• Device Catalogue Number: 504606X
• Device Lot Number: 17933934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 03/30/2021; 03/30/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 04/18/2021; 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1