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

Model Number D138502

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

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 and a hemostatic valve leak and separation issues occurred.The hub of the vizigo¿ sheath had blood coming back from it and it was noticed prior to inserting the pentaray.The valve was damaged internally, and blood was flowing backwards out of it.The clear/white hemostasis valve was tilted internally.The hemostasis valve looked to be in one piece.The hemostatic valve/brim cap/hub did not become detached from the sheath.One of the nurses also noticed that there was a kink on the dilator.Air did not enter the patient¿s body.This issue did not require percutaneous or surgical removal.Hemodynamics were not compromised due to bleeding.The approximate volume of blood that was lost is 100cc.The sheath was replaced, and the issue resolved.There was no patient consequence.

Manufacturer Narrative

On 12-nov-2021, 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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 16-nov-2021, it was noted that there was a change in the imdrf coding.Therefore, the h6.Medical device problem code was updated on this report from material twisted / bent (a040609) to material deformation (a0406).These codes are not mdr reportable, as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.

Manufacturer Narrative

The device evaluation was completed on 2-dec-2021.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 and a hemostatic valve leak and separation issues occurred.The hub of the vizigo¿ sheath had blood coming back from it and it was noticed prior to inserting the pentaray.The valve was damaged internally, and blood was flowing backwards out of it.The clear/white hemostasis valve was tilted internally.The hemostasis valve looked to be in one piece.The hemostatic valve/brim cap/hub did not become detached from the sheath.One of the nurses also noticed that there was a kink on the dilator.Air did not enter the patient¿s body.This issue did not require percutaneous or surgical removal.Hemodynamics were not compromised due to bleeding.The approximate volume of blood that was lost is 100cc.The sheath was replaced, and the issue resolved.There was no patient consequence.Device evaluation details: the device 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 that the hemostatic valve was missing in the vizigo sheath.The brim cap and the silicone ring were placed in the correct position and found in good condition.The dilator was not returned, so the condition could not be evaluated.It should be noted that product failure is multifactorial.Based on the information currently available.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, however, the hemostatic valve was missing and this cannot be conclusively determined.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 for the finished device 00001772 number, and no internal actions 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.An internal corrective action has been opened to investigate this failure mode.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: 12741345
• MDR Text Key: 281584611
• Report Number: 2029046-2021-01870
• 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,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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