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

Model Number D138502

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

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

Event Date 06/03/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation occurred.It was reported that when the dilator was inserted into the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, the hemostatic valve folded onto itself in the sheath.They were unable to insert the dilator into the sheath.When the sheath was replaced, the issue resolved.The sheath was not being used on the patient.

Manufacturer Narrative

Device investigation details: a picture showing the hemostatic valve appears dislodged in the hub was received for analysis.The device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.A device history record evaluation was performed, and no internal action related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.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.(b)(4).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 flutter (afl) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation occurred.It was reported that when the dilator was inserted into the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, the hemostatic valve folded onto itself in the sheath.They were unable to insert the dilator into the sheath.When the sheath was replaced, the issue resolved.The sheath was not being used on the patient.Device evaluation details: on 14-sep-2022, the product was returned to biosense webster (bwi) for evaluation.Visual inspection, and microscopic examination of the returned device were performed following bwi procedures, and the evaluation has been completed.Visual analysis revealed that the hemostatic valve was dislodged inside the hub component.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).After the valve was removed a dilator and a good known lab sample catheter were introduced through the sheath, and resistance was felt.No obstructions were detected.A device history record was performed for the finished device batch number, and no internal actions were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.An internal corrective action has been opened to investigate resistance issue.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.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14841555
• MDR Text Key: 301990542
• Report Number: 2029046-2022-01448
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• 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
• Report Date: 10/12/2022

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: 03/20/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2022
• 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: 8.5F SHEATH WITH CURVE VIZ MDC