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

Model Number D138501

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

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

Event Date 01/05/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small.The hemostatic valve was leaking.It was reported that the dilator was able to be advance through the vizigo¿ sheath and there was a leakage of blood more than usual coming from the hemostatic valve.The vizigo¿ sheath was replaced and the issue was resolved.The case continued.There was no physical damage on valve/hub.The hemostasis valve (gasket) did not break into two or more separate pieces.The hemostatic valve/brim cap/hub did not become detached from the sheath.Air did not enter the patient¿s body.This issue did not require percutaneous or surgical removal.The hemodynamics were not compromised due to bleeding.The approximate volume of blood that was lost was minimal, unable to provide a numerical approximation.No medical intervention was required to stop the bleeding.No patient consequences were reported.On 13-jan-2022, bwi received additional information regarding the event.Slight resistance was reported.The resistance they were having with the sheath was when the dilator advancing into sheath.Valve looked damaged.There was no occlusion when irrigating the sheath.The sheath was narrowed and the dilator was not able to be moved through the sheath.The dilator was not stuck in the sheath.The damage did not result in wires being exposed or any lifted or sharp rings.Obstructed dilator is not mdr-reportable.Hemostatic valve leak is mdr-reportable.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 26-jan-2022, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 3-mar-2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small.The hemostatic valve was leaking.It was reported that the dilator was able to be advance through the vizigo¿ sheath and there was a leakage of blood more than usual coming from the hemostatic valve.The vizigo¿ sheath was replaced and the issue was resolved.The case continued.Device evaluation details: visual analysis of the returned sample revealed that the hemostatic valve was missing on the hub of the carto vizigo sheath.For this reason, a guide wire was inserted through the sheath and the valve was not found inside the vizigo; however, the valve separated from the device.Examination of the brim cap and the silicone ring revealed the components were placed in the correct position and found in good conditions, also some bends were found on the vessel dilator.The functional test was performed, in accordance with bwi procedures.The vessel dilator and stsf catheter were introduced into the vizigo sheath and some resistance was felt during the testing.The od vessel dilator was measured, and it was within specifications.However, due to the condition of the hemostatic valve, an internal action was opened.A device history record review was performed for the finished device 00001839 number, and no internal actions related to the complaint were found during the review.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." 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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13329871
• MDR Text Key: 289005102
• Report Number: 2029046-2022-00147
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1