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

Model Number D138502

Device Problems Obstruction of Flow (2423); Contamination /Decontamination Problem (2895); Material Integrity Problem (2978)

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

Event Date 10/25/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium.It was also reported that the vizigo¿ sheath would not flush on the side arm port; they tried to check to see if there was a problem and found there was a blockage on the side arm port.The vizigo¿ sheath was replaced, and the issue was resolved.The case continued.No patient¿ consequences were reported.It was also reported that the vizigo sheath side arm (where fluid is injected) was obstructed where it meets the sheath hub.The hub and the sheath were all normal.The sheath never entered the patient¿s body.It appeared as there was a small covering of plastic that was obstructing where the side arm and sheath hub meet.Obstructed sheath is not mdr-reportable.Luer hub issue is not mdr-reportable.Foreign material on usable length of catheter is mdr-reportable.

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 reference number: (b)(4).

Manufacturer Narrative

On 16-feb-2023, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium.It was also reported that the vizigo¿ sheath would not flush on the side arm port; they tried to check to see if there was a problem and found there was a blockage on the side arm port.The vizigo¿ sheath was replaced, and the issue was resolved.The case continued.No patient consequences were reported.Device evaluation details: visual analysis revealed no damage or anomalies on the sheath and the dilator.An irrigation test was performed, a syringe was connected to the stopcock of the device, and irrigation was attempted; however, a blockage of the irrigation feature was detected.A guidewire was introduced inside the hub and a blockage in this area was detected, the hub was cut and a ftir study was performed on the material occluding the irrigation feature and revealed that this material is [ftir material composition].Due to this finding, a supplier manufacturing investigation was required.The supplier manufacturing investigation concluded as follows: it was confirmed that the failure mode involved a blockage of the stopcock tubing.Subsequenty, corrective and preventive actions were taken through capa was created to further address the occluded luer hub complaints.Therefore, it was concluded that this issue is manufacturing related.A device history record was performed for the finished device number lot 50000180 and no internal action related to the complaint was found during the review.The issue reported by the customer was confirmed.The instruction for use (ifu) states that ¿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¿ and ¿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: 15832115
• MDR Text Key: 307776553
• Report Number: 2029046-2022-02889
• 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: 03/10/2023

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: 07/12/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 02/16/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• 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: CARTO 3 SYSTEM.; SOUNDSTAR CATHETER.