MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL; INTRODUCER, CATHETER

Model Number D138501

Device Problems Partial Blockage (1065); Material Separation (1562)

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

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure for atrial fibrillation (afib) with a carto vizigo¿ 8.5f bi-directional guiding sheath - small where a hemostatic valve separation issue and an inadequate irrigation issue occurred.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath - small was unable to be flushed properly while in the left atrium (la).Initially the sheath flushed properly but once it got into the la, they were not able to flush it anymore.At that point, bleed back was noticed coming from the proximal part of the sheath.The sheath was replaced, and the issue was resolved.Hemostatic valve separation was not seen.No sections were showing visible breaks or separations.The hemostatic valve did not appear to be broken in 2 pieces.No air entered the patient¿s body.No percutaneous or surgical removal was required.Hemodynamics of the patient were not compromised due to bleed back.No medical intervention was needed to stop the bleeding.There was no report of thrombus or patient consequence.The hemostatic valve issue was assessed as a mdr reportable hemostatic valve separation.In addition, the inadequate irrigation issue was also assessed as mdr reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2021.The device evaluation was completed on (b)(6) 2021.It was reported that a patient underwent a cardiac ablation procedure for atrial fibrillation (afib) with a carto vizigo¿ 8.5f bi-directional guiding sheath - small where a hemostatic valve separation issue and an inadequate irrigation issue occurred.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath - small was unable to be flushed properly while in the left atrium (la).Initially the sheath flushed properly but once it got into the la, they were not able to flush it anymore.At that point, bleed back was noticed coming from the proximal part of the sheath.The sheath was replaced, and the issue was resolved.Hemostatic valve separation was not seen.No sections were showing visible breaks or separations.The hemostatic valve did not appear to be broken in 2 pieces.No air entered the patient¿s body.No percutaneous or surgical removal was required.Hemodynamics of the patient were not compromised due to bleed back.No medical intervention was needed to stop the bleeding.There was no report of thrombus or patient consequence.The device was visually inspected and the hemostatic valve was found dislodged into the hub.It was determined that the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve since stress marks and physical damage on the outer diameter were observed under microscope which suggest that excessive force was applied.According to the odp (optimal performance guide), there are some precautions on inserting the dilator into the vizigo sheath - always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.- do not insert a dilator at an angle, as damage to the sheath valve may occur.A device history review was performed for the finished device, and no internal actions related to the complaint was found during the review.The issue reported by the customer was confirmed.It appears to be related to the incorrect introduction of the vessel dilator.The odp (optimal device performance guide) provides additional instructions on how to insert the dilator into the sheath.In addition, there is evidence that the device was manufactured in accordance with documented specification and procedures.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11021385
• MDR Text Key: 229528116
• Report Number: 2029046-2020-01953
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND SHEATH