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

Model Number D138501

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 23-aug-2022.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.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.Manufacturer's reference number: pc-(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 three stop cock was broken.After the procedure was completed and the carto vizigo¿ 8.5f bi-directional guiding sheath - small was removed from the patient, it was discovered that there was a leak on one of the female ends of the flushing ports of the carto vizigo¿ 8.5f bi-directional guiding sheath - small.There was a backflow of blood discovered.After removing the carto vizigo¿ 8.5f bi-directional guiding sheath - small from the body, they flushed the carto vizigo¿ 8.5f bi-directional guiding sheath - small, and a significant amount of fluid leaked from the port.The female port where the leak occurred, completely broke off while flushing the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small after being removed from the patient's body.There was no injury to the patient at the time.The technician informed the biosense webster, inc.Representative that no leaks or cracks were noticed while flushing prior to the procedure beginning.It was also noted that a bubble error was displayed on the smartablate pump once during the procedure and that the physician resolved by striking the ablation catheter and carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small with a metal instrument.Additional information was received on 08-aug-2022.The flushing port in line with the patient end was the section of the 3- way stop cock that broke off and detached.Appeared to be 2 separate pieces.The hub appeared to still be attached.Sheath was being used on the patient when there was a crack and was leaking.The flushing port did not break off until the sheath was removed from the patient.An unknown amount of air entered the patient.No extraordinary measures were taken to remove the sheath.Blood return was noticed.Hemodynamics did not appear to be compromised.Normal amount of blood/fluid on the sterile field.Sheaths removed as normal, and no extraordinary interventions required.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) after further review on 27-dec-2022, the h6.Medical device problem code was updated from crack (a0404) to fluid leak (a050401) to better reflect the three stop cock issue reported.

Manufacturer Narrative

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 three stop cock was broken.The investigation was completed on 27-feb-2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the 3-way stop cock with extension tubing was noted broken, this condition is related to the customer's complaint regarding "the female port where the leak occurred completely broke off while flushing the vizigo sheath after being removed from the patient's body." the customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the luer hub was broken.A device history record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue broke off reported by the customer was confirmed.Based on this failure mode an internal corrective action was opened to investigate this three-way stopcock issue.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: -investigation findings: appropriate term/code not available (c22)/ investigation conclusions: cause not established (d15) were selected as related to the picture provided.-investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: valve(s) (g04135) were selected as related to the customer¿s reported ¿side port leakage¿ issue¿.-investigation findings: fracture problem (c070603) / investigation conclusions: cause traced to manufacturing (d03) / component code: valve(s) (g04135) were selected as related to the customer¿s reported ¿side port leakage¿ issue¿.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: 15686492
• MDR Text Key: 306790141
• Report Number: 2029046-2022-02666
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2023
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00002017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2022
• 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: UNKNOWN BRAND ABLATION CATHETER; UNK_SMARTABLATE PUMP