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

Catalog Number D138501

Device Problems Partial Blockage (1065); Break (1069)

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

Event Date 06/28/2023

Event Type  malfunction  

Manufacturer Narrative

E.1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and the tubing for flushing came off.It was reported that in the final stage of the procedure, tubing for flush (sideport) came off and totally separated.Since it was in the final stage of the procedure, so it was continued and completed.The physician performed a maneuver to eliminate bubbles.The irrigation was inadequate.There is no photo available.There was no patient consequence as the sheath was not used on the patient.

Manufacturer Narrative

On 3-aug-2023, 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.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

The device evaluation was completed on (b)(6) 2023.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and the tubing for flushing came off.It was reported that in the final stage of the procedure, tubing for flush (sideport) came off and totally separated.Since it was in the final stage of the procedure, so it was continued and completed.The physician performed a maneuver to eliminate bubbles.The irrigation was inadequate.There is no photo available.There was no patient consequence as the sheath was not used on the patient.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection and microscopic examination were performed following bwi procedures.Visual analysis revealed that the three way-valve was separated from the side port.Microscopic examination was performed, and evidence of polyurethane (pu) was found confirming a correct assembly manufacturing process.The damage observed could be related to the manipulation of the device during the procedure, however, this cannot be conclusively determined.A device history review (dhr) was performed for the finished device 60000107 number, and no internal actions related to the complaint were found during the review.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.An internal corrective action has been opened to introduce optimization actions on devices with this type of issue.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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: 17397720
• MDR Text Key: 319930041
• Report Number: 2029046-2023-01595
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Catalogue Number: D138501
• Device Lot Number: 60000107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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: NON-BWI NRG RF TRANSSEPTAL NEEDLE.