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

Model Number D138501

Device Problems Material Separation (1562); Obstruction of Flow (2423)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent an unknown ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small.During prep irrigation was an issue and the doctor thought the hemostatic valve was damaged.During the preparation of the vizigo sheath the irrigation was not proper.The doctor thought the valve was damaged.It is unknown if the irrigation was completely occluded or partially.The issue appeared before starting the procedure.The physician realized that there was something wrong when flushing the sheath with a syringe.The bwi company representative did not observe any damage but there was something wrong while flushing the sheath.We don't know if it's in the valve or any other part of the sheath.It is unknown if the hemostatic valve/brim cap/hub became detached from the sheath.The hemostasis valve (gasket) did not break into two or more separate pieces.It is unknown if the physician felt resistance between the catheter and the sheath.Another vizigo was used.There was no patient consequences.The issue appeared before starting the procedure, therefore, no catheter was used at the moment.Obstructed sheath is not mdr-reportable hemostatic valve - separation is mdr-reportable.

Manufacturer Narrative

On 31-aug-2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that an unknown patient underwent an unknown ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small.During prep irrigation was an issue and the doctor thought the hemostatic valve was damaged.Device evaluation details: visual analysis revealed that the hemostatic valve was dislodged inside the hub component.A microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The stress marks suggest that excessive force or manipulation was applied due to an extreme off-axis angle of insertion.Valve dislodgement occurs when extreme off-axis angles are performed during insertion with the dilator, outside of what is recommended in the odp (optimal device performance guide).No was found obstruction inside of the sheath.A device history record review was performed for the finished device 00001963 number, and no internal actions related to the complaint were found during the review.The issue reported by the customer was confirmed.The odp contains the following caution: 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.No was found resistance inside the device.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15234402
• MDR Text Key: 305349505
• Report Number: 2029046-2022-01889
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2023
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• 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