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

Model Number D138503

Device Problem Material Separation (1562)

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

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and a hemostatic valve separation occurred.It was reported that the hemostatic valve on the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large dislodged when inserting the dilator into the sheath.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large was replaced and the issue resolved.The procedure continued.There was no patient consequence.Additional information received indicated the white valve inside the clear plastic hub on the vizigo sheath dislodged during insertion of the dilator.The gasket did not break only dislodge and never became detached from the sheath.The complaint was noted prior to the sheath being inserted into the patient¿s body and therefore was never inserted.

Manufacturer Narrative

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and a hemostatic valve separation occurred.It was reported that the hemostatic valve on the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large dislodged when inserting the dilator into the sheath.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large was replaced and the issue resolved.The procedure continued.There was no patient consequence.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation on 13-jan-2022 and the evaluation has been completed.Bwi conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the hemostatic valve was dislodged inside the hub of the carto vizigo sheath.Examination of the brim cap and the silicone ring revealed the components were placed in the correct position and found in good conditions.A device history record was performed for the finished device batch number, and no internal actions were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.However, due to the conditions observed in the hemostatic valve, an internal corrective action has been opened to address this issue.It should be noted that product failure is multifactorial.Based on the information currently available, a microscopic examination of the returned product indicates that the hemostatic valve was found dislodged into the hub.It was determined that the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve, the stress marks, and physical damage observed which suggest that excessive force was applied.According to the odp (optimal performance guide), there are some precautions on inserting the dilator into the vizigo sheath: ¿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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13101608
• MDR Text Key: 285053996
• Report Number: 2029046-2021-02260
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Device Lot Number: 00001823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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: 8.5F SHEATH WITH CURVE VIZ LGC