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

Model Number D138501

Device Problem Material Separation (1562)

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

Event Date 09/28/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a hemostatic valve separation issue occurred.It was reported that the device was unable to flush due to dislodgement of the hemostatic valve.The event occurred when the sheath was into the inguinal canal.The issue was resolved by changing the vizgo to another one.The procedure was successfully completed.No adverse patient consequence was reported.The hemostatic valve separation issue is mdr reportable.

Manufacturer Narrative

(b)(6).The biosense webster, inc.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 29-nov-2022.There was no damage except for hemostatic valve dislodgement.Hemostatic valve was dislodged inside the hub but not outside the hub.The brim cap/hub did not detach from the sheath.No picture available.Sheath was used on the patient.No treatment required.There was no reflux of blood.The device evaluation was completed on 09-nov-2022.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small product was returned to biosense webster for evaluation.Bwi then conducted a visual inspection and a functional test of the side port.Visual analysis of the returned sample revealed that no damage was observed on the vizigo¿ sheath.The returned sample was connected to a syringe with water and no leakage was observed.In addition, the functional test of the side port was performed, and no issues were observed.A device history record (dhr) evaluation was performed for the finished device 00002014 number, and no internal action related to the complaint was found during the review.Based on the dhr, the h4.Device manufacture date has been updated.The hemostatic valve dislodged reported by the customer was not 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.The odp contains the following caution: always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.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: 15671906
• MDR Text Key: 307005601
• Report Number: 2029046-2022-02645
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

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: 05/31/2023
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00002014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 11/09/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• 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: UNK_CARTO VIZIGO SHEATH