MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI+ 7F STD W/GW NO OBT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	504607X
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	06/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot# 18095203 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 or Problem Description
As reported, at the end of a general anesthesia (ga) atrial fibrillation (af) ablation, the electrophysiology (ep) fellow went to remove a 7f 11cm avanti plus standard catheter sheath introducer (csi) with guidewire, no obturator.The fellow was removing the 7f avanti csi along with two 8f avanti plus 11cm csi¿s, all from the right femoral vein, when the 7f avanti csi broke, leaving 8cm of the shaft within the patient¿s vein which was confirmed via x-ray.A vascular surgeon was then called to review if a surgical cut-down would be required; however, it was decided to obtain an additional vascular access under the existing puncture site with an unknown 7f csi.This was followed by the use of a non-cordis snaring device to snare the separated portion of the 7f avanti csi and remove it percutaneously without need for a vascular cut down.Additional information was requested but was not provided.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: complaint conclusion: as reported, at the end of a general anesthesia, atrial fibrillation ablation, the electrophysiology fellow went to remove a 7f 11cm avanti plus standard catheter sheath introducer (csi) with guidewire, no obturator.The fellow was removing the 7f avanti csi along with two 8f avanti plus 11cm csi¿s, all from the right femoral vein, when the 7f avanti csi broke, leaving 8cm of the shaft within the patient¿s vein which was confirmed via x-ray.A vascular surgeon was then called to review if a surgical cut-down would be required; however, it was decided to obtain an additional vascular access under the existing puncture site with an unknown 7f csi.This was followed using a non-cordis snaring device to snare the separated portion of the 7f avanti csi and remove it percutaneously without need for a vascular cut down.The product was not returned for analysis.A product history record (phr) review of lot 18095203 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 event ¿cannula- separated - in patient¿ could not be confirmed.Insertion difficulties resulting in damage to the csi and/or withdrawing the device against resistance may have contributed to the reported event.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.¿ 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, at the end of a general anesthesia (ga) atrial fibrillation (af) ablation, the electrophysiology (ep) fellow went to remove a 7f 11cm avanti plus standard catheter sheath introducer (csi) with guidewire, no obturator.The fellow was removing the 7f avanti csi along with two 8f avanti plus 11cm csi¿s, all from the right femoral vein, when the 7f avanti csi broke, leaving 8cm of the shaft within the patient¿s vein which was confirmed via x-ray.A vascular surgeon was then called to review if a surgical cut-down would be required; however, it was decided to obtain an additional vascular access under the existing puncture site with an unknown 7f csi.This was followed by the use of a non-cordis snaring device to snare the separated portion of the 7f avanti csi and remove it percutaneously without need for a vascular cut down.Additional information was requested but was not provided.The device was not returned as expected.

• Brand Name: SI AVANTI+ 7F 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
• 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: 15102679
• Report Number: 9616099-2022-05847
• Device Sequence Number: 4150076
• Product Code: DRE
• UDI-Device Identifier: 20705032010105
• UDI-Public: (01)20705032010105(17)250228(10)18095203
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 504607X
• Device Catalogue Number: 504607X
• Device Lot Number: 18095203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/16/2022
• Date Device Manufactured: 03/16/2022
• 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: 8F AVANTI PLUS 11CM CSI; 8F AVANTI PLUS 11CM CSI; MERIT ENSNARE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown