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

Model Number D138503

Device Problems Material Separation (1562); Obstruction of Flow (2423)

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

Event Date 07/28/2022

Event Type  malfunction  

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).

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 ¿ large.The hemostatic valve was broken.It was reported that the hemostatic valve of the vizigo sheath was broken and there was bleed back.Additionally, the pentaray while being advanced in the sheath met resistance and bent.They exchanged the sheath and the catheter, and the issue was resolved, the case continued without any further incident.No patient consequences were reported.Obstructed sheath is not mdr-reportable.Hemostatic valve separation is mdr-reportable.

Manufacturer Narrative

On 24-aug-2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently 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 ¿ large.The hemostatic valve was broken.Device evaluation details: visual analysis revealed that the hemostatic valve was dislodged inside the hub component.Microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The stress marks suggest that excessive force or manipulation was applied due to an extreme off axis angle of insertion.Valve dislodgement occurs when extreme off axis angles are performed during insertion with the dilator, outside of what is recommended in the odp (optimal device performance guide).The resistance issue described by the customer could be related to this issue, the dislodged valve could have generated resistance against the dilator while it was being advanced through the sheath.The dilator was inserted once the dislodged valve was removed but no resistance was noticed, therefore, the dislodged valve could be related to the resistance issue described by the customer.A device history record evaluation was performed for the finished device number 00001956 and no internal action was found during the review.The issue reported by the customer was confirmed.The odp 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 ¿ LARGE.
• 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: 15234664
• MDR Text Key: 305155487
• Report Number: 2029046-2022-01891
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• 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
• Report Date: 09/12/2022

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: 04/01/2023
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Device Lot Number: 00001956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2022
• 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
• Treatment: PENTARAY NAV