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 11/26/2021

Event Type  malfunction  

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).

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 ¿ medium and a hemostatic valve separation issue occurred.It was reported that when the sheath was flushed they noticed that the valve was broken.The sheath was exchanged and the issue was resolved.The procedure continued without any further incident.Additional information was received on the event.The valve on the valve hub broke.The hemostasis valve (gasket) did not break into two or more separate pieces.The hemostatic valve/brim cap/hub did not become detached from the sheath.The sheath was not being used on the patient.The event was assessed as a mdr reportable hemostatic valve separation issue.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 03-jan-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.Manufacturer's reference number: (b)(4).

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 ¿ medium and a hemostatic valve separation issue occurred.It was reported that when the sheath was flushed they noticed that the valve was broken.The sheath was exchanged and the issue was resolved.The procedure continued without any further incident.Additional information was received on the event.The valve on the valve hub broke.The hemostasis valve (gasket) did not break into two or more separate pieces.The hemostatic valve/brim cap/hub did not become detached from the sheath.The sheath was not being used on the patient.The device evaluation was completed on 25-jan-2022.Product involved: vizigo sheath.The product was returned to biosense webster for evaluation.Bwi then conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the hemostatic valve was detached.(the valve was not returned and no evidence of dislodgement inside the hub was found), the brim cap and silicone ring were found in normal condition.The dilator was not returned.Another dilator was inserted on sheath and no resistance was felt.It should be noted that product failure is multifactorial.Based on the information currently available, an examination of the returned product indicates that the hemostatic valve was found detached.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, which suggests 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.¿ a device history record (dhr) was performed, and no non-conformances related to the complaint were found during the review.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 ¿ 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13041297
• MDR Text Key: 288361059
• Report Number: 2029046-2021-02219
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• 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,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• 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: UNKNOWN BRAND SHEATH.