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

Model Number D138501

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an atrial flutter right (r-afl) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small.The hemostatic valve would come out from the sheath and stay attached to the dilator on the first sheath and the brim cap detached.It was reported back flow from the valve.The sheath was replaced, and the issue resolved.They then noticed the valve would come out from the sheath and stay attached to the dilator on the first sheath.The hemostatic valve and hub section broke/separated.The hemostasis valve (gasket) did not dislodge inside or outside the hub, they stayed together onto the dilator.The brim cap/hub became detached from the sheath.The sheath was being prepped for use.Air did not enter the patient¿s body.The approximate volume of blood that was lost was not much, the exact amount is unknown.No patient consequences were reported.Hemostatic valve separation (externally) is mdr-reportable.Brim cap detachment is mdr-reportable.

Manufacturer Narrative

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.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 27-dec-2022, the photo investigation was completed.Device investigation details: following biosense webster (bwi)'s procedures, a picture was received for evaluation.According to the picture provided by the customer, the brim cap was detached from the hub and it was attached to the dilator.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.A device history record evaluation was performed for the finished device number 00002051, and no internal actions related to the reported condition were identified.The issue reported by the customer was confirmed based on the picture received.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.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).

Manufacturer Narrative

On 3-oct-2022, bwi received additional information indicating that the issue noted was with one sheath.The second one resolved all problems.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 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

On 13-jan-2023, the product investigation was completed.It was reported that an unknown patient underwent an atrial flutter right (r-afl) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small.The hemostatic valve would come out from the sheath and stay attached to the dilator on the first sheath and the brim cap detached.It was reported back flow from the valve.The sheath was replaced, and the issue resolved.They then noticed the valve would come out from the sheath and stay attached to the dilator on the first sheath.Device evaluation details: visual analysis revealed no damage or anomalies on the sheath and the dilator, also, the brim cap was observed attached to the hub, and no evidence of damages on the hemostatic valve were observed.The dilator and a good known lab sample catheter were introduced through the sheath, and no obstruction or resistance was felt.Although the photo provided shows the brim cap detached, during the analysis of the physical product no anomalies were observed with the brim cap of the vizigo sheath.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.Device history record evaluation was performed for the finished device (b)(6) number, and no internal actions related to the reported complaint condition were identified.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15526564
• MDR Text Key: 302369991
• Report Number: 2029046-2022-02378
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00002051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 10/03/2022; 12/02/2022; 12/27/2022; 01/13/2023
• Supplement Dates FDA Received: 10/25/2022; 12/20/2022; 12/29/2022; 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• 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