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

Model Number D138502

Device Problem Material Separation (1562)

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

Event Date 08/24/2022

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 ¿ medium and a hemostatic valve separation issue occurred.During preparation of the vizigo¿ sheath, before starting the procedure, when inserting the dilator into the sheath, the hemostatic valve became loose.It was somewhat pushed into the sheath.The sheath was immediately replaced and prepared for complaint device return (dilator was removed to be able to put the sheath into the bag.) unfortunately, packaging was already dispensed so lot number is unknown.The event occurred during sterile processing and during field inspection.The event did not occur during internal service activities such as calibration.There were no patient consequences.As far as it was noticed, the hemostatic valve was dislodged.It seemed like the gasket dislodged inside the hub.The hemostatic valve did not dislodge outside the hub, as the valve is still inside the hub.The brim cap/hub did not become detached from the sheath.The sheath was already inserted in the patient.There were no reports of any air entering the patient¿s body, nor of any patient consequences or any required treatment.Apparently, there was blood returned, due to stains on the device.The approximate volume of blood that was lost was very little, less than 10ml.

Manufacturer Narrative

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

The biosense webster, inc.Product analysis lab received the device for evaluation on 23-sep-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.During initial evaluation, the lot number was verified to be 50000174.This was verified by electronically erasable programmable read only memory (eeprom) file.Therefore, the d 4.Lot, d 4.Expiration date, and h 4.Device manufacture date have been updated.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

The device evaluation was completed on (b)(6)2022.It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation issue occurred.During preparation of the vizigo¿ sheath, before starting the procedure, when inserting the dilator into the sheath, the hemostatic valve became loose.It was somewhat pushed into the sheath.The sheath was immediately replaced and prepared for complaint device return (dilator was removed to be able to put the sheath into the bag.) unfortunately, packaging was already dispensed so lot number is unknown.The event occurred during sterile processing and during field inspection.The event did not occur during internal service activities such as calibration.There were no patient consequences.As far as it was noticed, the hemostatic valve was dislodged.It seemed like the gasket dislodged inside the hub.The hemostatic valve did not dislodge outside the hub, as the valve is still inside the hub.The brim cap/hub did not become detached from the sheath.The sheath was already inserted in the patient.There were no reports of any air entering the patient¿s body, nor of any patient consequences or any required treatment.Apparently, there was blood returned, due to stains on the device.The approximate volume of blood that was lost was very little, less than 10ml.Device evaluation details: according to the picture provided by the customer, the hemostatic valve was dislodged inside the hub component.The product was returned to biosense webster for evaluation.Visual inspection and microscopic examination of the returned device were performed following bwi procedures.Visual analysis revealed that the hemostatic valve was dislodged inside the hub component.However, no damage was observed on the dilator.A microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The stress marks suggest that excessive force or manipulation was applied due to an extreme off-axis angle of insertion.Valve dislodgement occurs when extreme off-axis angles are performed during insertion with the dilator, outside of what is recommended in the odp (optimal device performance guide).A device history record evaluation was performed for lot 50000174 and no internal actions related to the complaint were found during the review.The issue reported by the customer was confirmed.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 biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.H6.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15465816
• MDR Text Key: 301096248
• Report Number: 2029046-2022-02287
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2022

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: 06/23/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 09/23/2022; 11/05/2022
• Supplement Dates FDA Received: 10/04/2022; 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• 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 BRAND SHEATH