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

Model Number D138502

Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250)

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

Event Date 10/11/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 ref.#pc-(b)(4).

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation occurred.It was reported the hemostatic valve of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was leaking.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was exchanged, and the procedure was continued.After transseptal, the physician noted that he was not able to flush the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.They believed that the valve was dislodged inside the hub which couldn't aspirate or flush the sheath.After unsuccessful attempts to flush or aspirate the sheath, physician decide to exchange the sheath and avoid serious consequences to the patient.

Manufacturer Narrative

On 8-nov-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.Manufactur.Er's ref.#(b)(4).

Manufacturer Narrative

It was reported that an unknown patient underwent an atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation occurred.It was reported the hemostatic valve of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was leaking.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was exchanged, and the procedure was continued.After transseptal, the physician noted that he was not able to flush the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.They believed that the valve was dislodged inside the hub which couldn't aspirate or flush the sheath.After unsuccessful attempts to flush or aspirate the sheath, physician decide to exchange the sheath and avoid serious consequences to the patient.Device evaluation details: on 21-dec-2022, the product investigation was completed.Visual analysis revealed that the hemostatic valve was dislodged inside of hub component.Microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The damage observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve; the stress marks and physical damage observed suggest that excessive force or manipulation was applied; however, this could not be conclusively determined.A device history record evaluation was performed for the finished device (b)(6) number, and no internal action related to the complaint was found during the review.The issue reported by the customer was confirmed.The odp (optimal device performance guide) 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15732080
• MDR Text Key: 307204893
• Report Number: 2029046-2022-02728
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2022
• 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
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC