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

Model Number	504615Z
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Vascular Dissection (3160)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After further review of additional information received.As reported, it was difficult to introduce a 5f 11cm avanti plus catheter sheath introducer (csi) into the artery due to the csi having a ¿fragile tip and a rough body¿.There were reports of vasospasm, radial artery dissection, and loss of radial pulse.The product was not returned for analysis.A product history record (phr) review of lot: 18088041 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 device or images for analysis, the reported customer events ¿vasospasm, artery dissection, vascular occlusion and csi-damaged.¿ could not be confirmed.It is not possible to determine if the device was damaged without performing a product evaluation.Vasospasm, artery dissection and vascular occlusion are known complications associated with radial access and may have been precipitated by attempting to insert the device against resistance.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, or an intravascular device through the csi, investigate the cause before continuing.If the cause cannot be determined and corrected, discontinue the procedure, and withdraw the csi.Possible complications include, but are not limited to air embolism, infection, intimal tear, hematoma, perforation of the vessel wall, thrombus formation.¿ 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.
Event or Problem Description
As reported, it was difficult to introduce a 5f 11cm avanti plus catheter sheath introducer (csi) into the artery due to the csi having a ¿fragile tip and a rough body¿.There were reports of vasospasm, radial artery dissection, and loss of radial pulse.Additional information was requested but was not provided.The device will not be returned for evaluation.

• Brand Name: AVANTI
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• MDR Report Key: 17292236
• Report Number: 9616099-2023-06548
• Device Sequence Number: 5537589
• Product Code: DRE
• UDI-Device Identifier: 10705032010276
• UDI-Public: (01)10705032010276(17)250131(10)18088041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2023

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 Model Number: 504615Z
• Device Catalogue Number: 504615Z
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown