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

Model Number D138502

Device Problems Material Separation (1562); Device-Device Incompatibility (2919)

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

Event Date 12/06/2021

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.When advancing the dilator into the sheath there was some resistance and the valve broke.The valve broke/separated.The hemostasis valve (gasket) split.The hemostatic valve/brim cap/hub did not become detached 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.The patient¿s hemodynamics were not compromised due to bleeding.No medical intervention was required to stop the bleeding.There was no physical damage on sheath/dilator.There was no occlusion when irrigating the sheath.The sheath was not narrowed, partially blocked nor completely blocked.The dilator was not able to be moved through the sheath.The dilator was not stuck on the sheath.The sheath was replaced, and the issue resolved.No patient consequence was reported.With the information available, this event was not assessed as a patient event but as a mdr reportable hemostatic valve separation product malfunction.

Manufacturer Narrative

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.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 04-feb-2022.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.When advancing the dilator into the sheath there was some resistance and the valve broke.The valve broke/separated.The hemostasis valve (gasket) split.The hemostatic valve/brim cap/hub did not become detached 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.The patient¿s hemodynamics were not compromised due to bleeding.No medical intervention was required to stop the bleeding.There was no physical damage on sheath/dilator.There was no occlusion when irrigating the sheath.The sheath was not narrowed, partially blocked nor completely blocked.The dilator was not able to be moved through the sheath.The dilator was not stuck on the sheath.The sheath was replaced, and the issue resolved.No patient consequence was reported.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed the absence of the hemostatic valve, it could be detached and lost during the manipulation of the vizigo¿ sheath.The brim cap and silicone ring were found in its place.The brim cap and the silicone ring were placed in the correct position and found in good condition.A device history record (dhr) was performed for the finished device 00001777 number, and no internal actions related to the complaint were found during the review.Based on the dhr, the h 4.Device manufacture date has been updated.A functional test was performed, in accordance with bwi procedures.The vessel dilator and stsf catheter were introduced into the vizigo¿ sheath and no resistance was felt during the testing with the vessel dilator.The od vessel dilator was measured, and it was within specifications.Based on the information currently available, indicates that the hemostatic valve was dislodged and lost during the procedure but, cannot be conclusively determined.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.The instructions for use contain the following recommendations: prior to inserting the device into the patient, pre-assemble the sheath, dilator, and stylet on the table.Advance the needle through the dilator and check for excessive resistance as the tip of the needle advances through the curvature of the sheath/dilator assembly.If resistance is encountered, do not use excessive force to advance or withdraw the catheter through the sheath.Explanation of codes: investigation findings: fracture problem (c070603)/ investigation conclusions: cause not established (d15)/ component code: valve(s) (g04135) were selected as related to the hemostatic valve separation.Investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14)/ were selected as related to the resistance with sheath.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: 13120247
• MDR Text Key: 287583480
• Report Number: 2029046-2021-02276
• 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: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND SHEATH