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 08/05/2022

Event Type  malfunction  

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 the hemostatic valve broke on the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.They exchanged the sheath and the issue was resolved.The case continued without any further incident.Additional information was received.The white distal valve split.Almost looks like the valve ripped and then could not keep a seal round catheter.The hemostatic valve/brim cap/hub did not detach from the sheath.The sheath was being used on the patient.Air did not enter the patient¿s body.This issue did not require percutaneous or surgical removal.Blood return was observed.The patient¿s hemodynamics were not compromised due to bleeding.The approximate volume of blood that was lost was 20 cc.No medical intervention was required to stop the bleeding.The event was assessed as mdr reportable for a hemostatic valve separation issue occurred.

Manufacturer Narrative

The product has not returned for analysis, however, pictures were provided by the customer.Evaluation is still in progress.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: (b)(4).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 31-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.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.The investigation was completed on 24-jan-2023.A picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, the hemostatic valve was observed damaged.This issue could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve; however, this could not be conclusively determined.The issue reported by the customer 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 (bwi) for evaluation.Visual inspection and microscopic examination of the returned device were performed following bwi procedures.Visual analysis revealed that the hemostatic valve is placed in its original place and broken in the star section.A device history record was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.The odp (optimal device performance guide) 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.This product issue will be addressed through bwi's quality system.An internal corrective action has been opened to reduce this failure mode.Explanation of codes: -investigation findings: appropriate term/code not available (c22)/ investigation conclusions: cause not established (d15) were selected as related to the photo provided.Investigation findings: fracture problem (c070603) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: valve(s) (g04135) were selected as related to the customer¿s reported issue of hemostatic valve separation.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15331592
• MDR Text Key: 305503170
• Report Number: 2029046-2022-02057
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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 CATHETER.; UNKNOWN BRAND SHEATH.