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

Model Number D138502

Device Problem Backflow (1064)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an unknown ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium.It was reported that when the octaray was inserted through the hemostasis valve, the airlock drew air.When the catheter was withdrawn, it also drew air.The user changed the sheath, and the procedure was completed.No patient consequence.Air was not introduced into the patient.Physician performed a maneuver to eliminate bubbles.No medical intervention required.The patient has not exhibited any neurological symptoms since the procedure was completed.No section of the device broke or separated.The hemostatic valve did not dislodge inside or outside the hub.The brim cap/hub did not detach from the sheath.No picture available.It was confirmed that the airlock of the sheath was concerning.Air flow into side port is mdr-reportable.

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).

Manufacturer Narrative

On 3-nov-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 ¿medium.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the vizigo sheath.A back pressure test was performed, and values were observed within specifications, no issues were observed.A device history record evaluation was performed for the finished device 50000176 number, and no internal action related to the complaint was found during the review.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendations: before inserting the sheath into the patient, flush the sheath and dilator with heparinized normal saline to remove air bubbles and any potential particulate.After the sheath is in the left atrium of the patient, maintain a constant flow of heparinized normal saline to the sheath to minimize the risk of air emboli.Flush and maintain continuous saline.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 ¿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: 15656899
• MDR Text Key: 307097155
• Report Number: 2029046-2022-02614
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• 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