MAUDE Adverse Event Report: CORDIS CORPORATION AVANTI + 5F STD W/GW; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	504605X
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	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of a 5f mynxgrip vascular closure device (vcd) ruptured during the retraction portion of the deployment procedure and the device came out of the body.The device was used with a 5f avanti + sheath, which appeared to have frayed on the end of the sheath after removal.Hemostasis was achieved by manual compression to the site.There was no patient injury.No excess force was applied during insertion.The patient was not morbidly obese.Nothing unusual was noted about the device prior to use.The device was removed from the package by the black handle.The device was used in an interventional peripheral procedure using a retrograde approach.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity, or presence of peripheral vascular disease or calcium present at the puncture site.There was no resistance or friction experienced when advancing the device into the sheath.There was no prior pta, stent, or vascular graft in the common femoral artery.The balloon lost pressure after being pulled to the arteriotomy.The balloon lost pressure at the 2nd stop.No resistance was noted during withdrawal of the sheath from the vessel.The product was removed intact from the patient.The device is being returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18075218 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.As reported, the balloon of a 5f mynxgrip vascular closure device (vcd) ruptured during the retraction portion of the deployment procedure and the device came out of the body.The device was used with a 5f avanti + sheath, which appeared to have frayed on the end of the sheath after removal.Hemostasis was achieved by manual compression to the site.There was no patient injury.No excess force was applied during insertion.The patient was not morbidly obese.Nothing unusual was noted about the device prior to use.The device was removed from the package by the black handle.The device was used in an interventional peripheral procedure using a retrograde approach.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity, or presence of peripheral vascular disease or calcium present at the puncture site.There was no resistance or friction experienced when advancing the device into the sheath.There was no prior pta, stent, or vascular graft in the common femoral artery.The balloon lost pressure after being pulled to the arteriotomy.The balloon lost pressure at the 2nd stop.No resistance was noted during withdrawal of the sheath from the vessel.The product was removed intact from the patient.182883-2 the product was returned for analysis.One non-sterile avanti + 5f std w/gw unit was received for analysis inside a plastic bag.The device was unpacked to proceed with the product evaluation.Per visual analysis, at naked eye the distal tip has an apparent damage, however, was not possible to observe the damage characteristics.Per sem analysis, the distal tip of the cannula was damaged/torn; however, the device was used.The exact cause of the observed characteristic could not be determined during analysis.A product history record (phr) review of lot 18075218 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 - frayed/split/torn - in patient¿ was confirmed during analysis of the returned device.The exact cause of the reported events could not be conclusively determined.Procedural and handling factors may have contributed to the reported events.The ifu warns users not to use devices that appear damaged in any way.Neither the phr review nor the information available suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• Brand Name: AVANTI + 5F STD W/GW
• 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 CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14278661
• Report Number: 9616099-2022-05607
• Device Sequence Number: 14752124
• Product Code: DRE
• UDI-Device Identifier: 20705032009987
• UDI-Public: (01)20705032009987(17)241130(10)18075218
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2022

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: 11/30/2024
• Device Model Number: 504605X
• Device Catalogue Number: 504605X
• Device Lot Number: 18075218
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 05/20/2022; 06/24/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/14/2022; 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MYNXGRIP VASCULAR CLOSURE DEVICE 5F
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 59 KG