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 06/27/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a hemostatic valve separation issue occurred.Initially it was reported that the outer cylinder (sheath) could not be flushed before it was inserted in the patient.After changed to a new product, the procedure was continued.The procedure was completed without patient's consequence.Multiple attempts were made to obtain clarification to this complaint.With the information available, this event was assessed as not mdr reportable for an obstructed sheath issue.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Additional information was received on 01-jul-2022.The white part (probably a hemostatic valve) seemed to have come off, and a part of it might have entered into the sheath and stuck.The hemostatic valve itself was not cracked and the dilator could be flushed, but sheath body could not be flushed.The hemostatic valve issue was assessed as mdr reportable for a hemostatic valve separation issue.The awareness date for this reportable issue is 01-jul-2022.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information was received on 22-july-2022.There was no physical damage on the sheath.Additional information was received on 26-july-2022.They were unable to be more specific on what section of the valve broke/separated.The hemostatic valve (gasket) did not break into two or more separate pieces or become detached from the sheath.The sheath was not being used on the patient; therefore, blood reflux was not observed.The bwi product analysis lab received the device for evaluation on 03-aug-2022.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

The device evaluation was competed on 02-sep-2022.It was reported that a patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a hemostatic valve separation issue occurred.Initially it was reported that the outer cylinder (sheath) could not be flushed before it was inserted in the patient.After changed to a new product, the procedure was continued.The procedure was completed without patient's consequence.Additional information was received.The white part (probably a hemostatic valve) seemed to have come off, and a part of it might have entered into the sheath and stuck.The hemostatic valve itself was not cracked and the dilator could be flushed, but sheath body could not be flushed.There was no physical damage on the sheath.They were unable to be more specific on what section of the valve broke/separated.The hemostatic valve (gasket) did not break into two or more separate pieces or become detached from the sheath.The sheath was not being used on the patient.The product was returned to biosense webster (bwi) for evaluation.Visual inspection and microscopic examination of the returned device were performed following bwi procedures.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).A device history record was performed for the finished device batch number, and no internal actions were identified.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.The valve dislodgement could be related to the obstruction reported by the customer.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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: 15079608
• MDR Text Key: 304518858
• Report Number: 2029046-2022-01675
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2023
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2022
• 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
• Treatment: UNKNOWN BRAND SHEATH