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); Material Twisted/Bent (2981)

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

Event Date 03/07/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The hemostatic valve was displaced.When the dilator was removed there was backflow of blood.There was a floating piece in the hemostatic valve.The sheath was exchanged with another vizigo and the procedure continued.No patient consequences were reported.The hemostatic valve was detached from the sheath.It is unknown if air entered the patient¿s body.The issue did not require percutaneous, surgical removal or medical intervention.Patient hemodynamics were not compromised due to bleeding.The approximate volume of blood that was lost was unknown but not a significant amount.Hemostatic valve separation is mdr-reportable.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: visual analysis revealed that the hemostatic valve was not found inside the device and the shaft was bent.The hemostatic valve detachment could be related to the dilator wrongly introduced; however, this could not be conclusively determined.A root cause for the bent shaft could not be determined, however, based on the information available this condition occurred outside the manufacturing facilities.A device history record evaluation was performed for the finished device number 00001872 and no internal action was found during the review.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.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 ; 6465917981
• MDR Report Key: 13983756
• MDR Text Key: 291945160
• Report Number: 2029046-2022-00670
• 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
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2021
• 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: VIZIGO SHEATH