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

Model Number D138502

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

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

Event Date 12/02/2021

Event Type  malfunction  

Event Description

A patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium for which biosense webster¿s product analysis lab identified that the hemostatic valve was not on the device.A guide wire was inserted through the sheath and the valve was not found within the vizigo.During the procedure, it was reported that the dilator was not able to go through the sheath.The sheath was replaced and the issue resolved.No patient consequences were reported.The sheath obstruction is not mdr-reportable.Hemostatic valve separation is mdr-reportable.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed the hemostatic was not on the device.For this reason, a guide wire was inserted through the sheath and the valve was not found inside the vizigo.Microscopic evaluation of the brim cap and the silicone ring revealed they were placed in the correct position and found in good conditions.A device history record was performed for the finished device 50000032 lot number, and no internal actions related to the complaint were found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.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." 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: 13574969
• MDR Text Key: 290786967
• Report Number: 2029046-2022-00327
• 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
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• 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