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	Partial Blockage (1065)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with this lot# 17906111 presented no issues during the manufacturing process that can be related to the reported complaint.This device is available 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, the 6f.072 4 x 100cm extra back-up (xb) adroit guiding catheter did not fit into the 6f avanti plus sheath introducer (si).The patient was fine.There was no reported patient injury.The device was prep according to the instructions for use (ifu).The procedure was percutaneous transluminal coronary angioplasty (ptca).The access site was femoral.There was no difficulty experienced in prepping the device.They did not use a contralateral approach.Vessel characteristics accessing target site is unknown.The device was not used for treatment of a chronic total occlusion.The device kink or bend during use prior to the resistance /friction.The insertion difficulty could have been caused by a blockage of possibly injectable material.The difficulty was encountered when advanced through a cordis catheter sheath introducer.No products were successfully used with the device after the encountered resistance.Only the reported product was removed, all concomitant products were not removed together.The product, or any of the other devices used were not resterilized.The devices are expected to be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g4, g7, h1,.Please note this case has been deemed non reportable after additional information was received.

• 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 60 avenue; miami lakes FL 33014
• MDR Report Key: 10521077
• Report Number: 9616099-2020-03898
• Device Sequence Number: 19726667
• Product Code: DRE
• UDI-Device Identifier: 20705032010051
• UDI-Public: 20705032010051
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K970392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 09/30/2022
• Device Model Number: 504606X
• Device Catalogue Number: 504606X
• Device Lot Number: 17906111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 09/12/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1