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

Model Number D138501

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Obstruction of Flow (2423)

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

Event Date 02/01/2022

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 ¿ small.The hemostatic valve was broken.The sheath met with resistance with the dilator.It was eventually seated but the hemostatic valve then started leaking.The sheath was replaced, and the case continued.Resistance occurred while inserting the dilator.There was no occlusion or issues while irrigating the sheath.The sheath was not either narrowed, partially blocked or completely blocked.The physician could not insert dilator.Replaced sheath without putting catheters in the body.The hemostatic valve 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 being used on the patient.Air did not enter 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 50-100 cc.Resistance with sheath is not mdr-reportable.Hemostatic valve separation is mdr-reportable.

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).

Manufacturer Narrative

On 21-feb-2022, the bwi 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

On 28-mar-2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.The hemostatic valve was broken.The sheath met with resistance with the dilator.It was eventually seated but the hemostatic valve then started leaking.The sheath was replaced, and the case continued.Device evaluation details: visual analysis of the returned sample revealed that the hemostatic valve was found dislodged inside of the hub of the vizigo sheath.In addition, some bents on the vessel dilator.Microscopic examination in the hemostatic valve surface has shown evidence of stress marks on the outer diameter.On other hand, the brim cap and the silicone ring were placed in the correct position and found in good conditions.The functional test was performed, in accordance with bwi procedures.The vessel dilator and stsf catheter were introduced into the vizigo sheath and some resistance was felt during the testing.The od vessel dilator was measured, and it was within specifications.Due to the conditions of the hemostatic valve, an internal action was opened.A device history record review was performed for the finished device 00001819 number, and no internal actions related to the complaint were found during the review.According to the odp (optimal device 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.Prior to inserting the device into the patient, pre-assemble 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.At this time is not possible to determine the root cause of the hemostatic valve condition, however, based on the information provided, the condition reported has origin in someplace external to the manufacturing environment.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 ¿ SMALL
• 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: 13509051
• MDR Text Key: 289007312
• Report Number: 2029046-2022-00264
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• 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: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2021
• 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: CARTO 3 SYSTEM; THERMOCOOL SMARTTOUCH; UNSPECIFIED CATHETER CABLE