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

Model Number D138502

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve leak occurred.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was inserted into the patient¿s body and that when the dilator was removed, blood leaked from the valve, so a replacement was performed.This occurred after it was inserted into the patient¿s body, during removal of the dilator.The procedure was completed by changing the sheath.Additional information was later received indicating there was no physical damage on the 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.Hemodynamics were not compromised due to bleeding.The approximate volume of blood lost was a few drops, but the exact amount is unknown.There was no medical intervention required to stop the bleeding.

Manufacturer Narrative

On 11-jan-2022, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve leak occurred.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was inserted into the patient¿s body and that when the dilator was removed, blood leaked from the valve, so a replacement was performed.This occurred after it was inserted into the patient¿s body, during removal of the dilator.The procedure was completed by changing the sheath.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi then conducted a visual inspection of the returned device.Visual analysis of the returned device revealed that the hemostatic valve and the silicon ring were missing from the vizigo's hub.This finding has been reviewed and determined the issue of the hemostatic valve separation/missing is considered to be an mdr reportable malfunction.It should be noted that product failure is multifactorial.It could be determined that the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve.However, this cannot be conclusively determined.A device history record evaluation was performed for the finished device number, and no internal actions related to the complaint were found during the review.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.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 ref.# (b)(4).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM
• 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: 13085932
• MDR Text Key: 287583261
• Report Number: 2029046-2021-02248
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/26/2021
• Supplement Dates Manufacturer Received: 01/11/2022; 02/07/2022
• Supplement Dates FDA Received: 02/01/2022; 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2021
• 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
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC; SOUNDSTAR ECO GE 8F CATHETER