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

Catalog Number D138502

Device Problems Fluid/Blood Leak (1250); Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath medium, when a lot of resistance was experienced while pushing the dilator into the sheath.The sheath was flushed a couple of times and after the second time, the fluid came out of the back of the valve.As a result, the sheath was replaced and the issue was resolved.Additional information was received indicating that the incident occurred prior to the start of the procedure.A transseptal needle was never inserted.There was no damage to the sheath, only to the dilator which was kinked trying to advance it into the sheath.Resistance was met when both trying to insert and remove the dilator.There was too much resistance met to advance the dilator past the half way point of the sheath.The hemostatic valve did not dislodge inside the hub or outside the hub.The brim cap/hub did not become detached from the sheath.

Manufacturer Narrative

Manufacturer's reference number: (b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 26-jan-2024.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

It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, when a lot of resistance was experienced while pushing the dilator into the sheath.The sheath was flushed a couple of times and after the second time, the fluid came out of the back of the valve.As a result, the sheath was replaced and the issue was resolved.Additional information was received.There was no damage to the sheath, only to the dilator which was kinked trying to advance it into the sheath.The device evaluation was completed on 20-feb-2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and microscopic examination of the returned device were performed following bwi procedures.Visual analysis revealed that the hemostatic valve was broken in the star section and the dilator was found broken.Microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The damage observed could be related to the incorrect insertion of the dilator into the sheath.The stress marks and physical damage observed suggest that excessive force manipulation was applied; however, this could not be conclusively determined.A device history record was performed for the finished device batch number, and no internal actions were identified.The issues reported by the customer were 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.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.The customer¿s reported ¿dilator kinked¿ issue was considered non-reportable.Per the device evaluation completion on 20-feb-2024 the bwi inc.Product analysis lab became aware of the ¿dilator broken¿ and have assessed this returned condition as reportable.The awareness date for this returned condition is 20-feb-2024.Explanation of codes: -investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: guide (g04061) were selected as related to the customer¿s reported ¿dilator kinked¿ issue.In addition, the biosense webster inc.Analysis finding of the ¿dilator broken¿ issue.-investigation findings: fracture problem (c070603) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: valve(s) (g04135) were selected as related to the customer¿s reported ¿resistance¿ and ¿fluid came out of the back of the valve¿ issues.In addition, the biosense webster inc.Analysis finding of the ¿hemostatic valve was broken in the star section¿ issue.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18576665
• MDR Text Key: 334751834
• Report Number: 2029046-2024-00288
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D138502
• Device Lot Number: 00002480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2023
• 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