MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI+ 8F STD W/GW NO OBT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17936012 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.

Event Description

As reported, during prep before a radiofrequency ablation puncture, hair was found at the distal end of the 8f standard (std) avanti plus catheter sheath introducer (csi) with guidewire (gw) no obturator (obt).There was a "black object" on the distal end of the device; similar to hair.The device was replaced immediately.There was no reported patient injury.There was no adverse event with this reported issue.This was noticed during prep, when the device was out of the package.The device was stored as per the instructions for use (ifu).There was no damage to the sterile packaging.The product had not been reshelved after previous opening in anticipation of use.Sterile protocol was maintained in the procedure room.The hospital has chosen to report this as an adverse event to the nmpa directly.The device is expected to be returned for analysis.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: during prep of a radiofrequency ablation puncture, hair was found at the distal end of an 8f standard (std) avanti plus catheter sheath introducer (csi) with guidewire (gw) no obturator (obt).There was a "black object" on the distal end of the device, similar to hair.The device was replaced immediately.There was no adverse event with this reported issue.This was noticed when the device was out of the package and during prep.The device was stored as per the instructions for use (ifu).There was no damage to the sterile packaging.The product had not been reshelved after previous opening in anticipation of use.Sterile protocol was maintained in the procedure room.The hospital has chosen to report this as an adverse event to the nmpa directly.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17936012 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) ¿ foreign material- during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported event could not be conclusively determined.Procedural factors, such as unsterile technique during prep, may have contributed to the reported event.Users are instructed to examine devices prior to use for any damages.According to the ifu, which is not intended as a mitigation of risk, ¿do not use if package is open or damaged.Remove csi from package using sterile technique.¿ neither the phr nor the information available suggests 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+ 8F STD W/GW NO OBT
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12458869
• MDR Text Key: 271051794
• Report Number: 9616099-2021-04859
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 10705032010153
• UDI-Public: (01)10705032010153(17)230228(10)17936012
• Combination Product (y/n): N
• PMA/PMN Number: K970392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 504608X
• Device Lot Number: 17936012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 75