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

Model Number D138502

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/07/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an atrial flutter right (r-afl) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The valve was leaking back blood.The vizigo sheath hemostatic valve was leaking back blood.A different dilator was inserted into the vizigo sheath, and it was noted there was no resistance, or anything indicating damage.The procedure continued using the same vizigo sheath.No patient consequences were reported.The hemostasis valve did not break and it did not become detached from the sheath.No air entered the patient¿s body.No intervention was necessary.Hemodynamics were not compromised due to bleeding.The approximate volume of blood that was lost was unknown.Hemostatic valve leak is mdr-reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.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.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 6-aug-2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial flutter right (r-afl) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The valve was leaking back blood.Device evaluation details: visual analysis of the returned sample revealed that no damage was observed on the vizigo sheath.The dilator was found in normal condition.Then, the returned sample was connected to a syringe with water and no leakage was observed.Then the functional test of the side port was performed, and no issues were observed.The device history record (dhr) for lot number 50000146 has been received and no internal actions related to the complaint were found during the review.The instructions for use contain the following warning stated in the instructions for use (ifu): 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.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15118908
• MDR Text Key: 302508781
• Report Number: 2029046-2022-01735
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2022
• 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