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

Model Number D138501

Device Problem Partial Blockage (1065)

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

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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).

Event Description

It was reported that an unknown patient underwent an unknown ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.Situation-water not able to pass through at the time of priming.The dilator was able to pass through.Timing when complaints occurred was before insertion to the patient¿s body, when priming.Resolved by replacing the vizgo sheath.The procedure was completed without patient's consequence.After confirming the issue, the dilator got bent when passing through the dilator for verification.Not related to this issue.Inadequate irrigation is mdr-reportable.

Manufacturer Narrative

On 15-feb-2023, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.Situation-water not able to pass through at the time of priming.The dilator was able to pass through.Timing when complaints occurred was before insertion to the patient¿s body, when priming.Resolved by replacing the vizgo sheath.The procedure was completed without patient's consequence.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 00002015 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).

Manufacturer Narrative

On 16-jan-2023, 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.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 ¿ SMALL.
• 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: 16119558
• MDR Text Key: 307198559
• Report Number: 2029046-2023-00057
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00002015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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