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

Model Number D138501

Device Problem Obstruction of Flow (2423)

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

Event Date 12/22/2021

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed that the hemostatic valve was found dislodged inside of the hub of the vizigo sheath.Also, the brim cap and silicone ring were found in normal condition.The vessel dilator was not returned and the vizigo shaft was inspected, and it was found in normal condition.Microscopic examination on the hemostatic valve surface showed evidence of stress marks on the outer diameter.On the other hand, the brim cap and the silicone ring were placed in the correct position and found in good conditions.Due to the conditions of the hemostatic valve, an internal action was opened.It should be noted that product failure is multifactorial.Based on the information currently available, a microscopic examination of the returned product indicates that the hemostatic valve was found dislodged into the hub.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, the stress marks, and physical damage observed which suggest that excessive force was applied.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 review was performed for the finished device 00001797 number, and no internal actions related to the complaint were found during the review.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

A patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath small analysis of the returned sample revealed that the hemostatic valve was found dislodged inside of the hub of the vizigo sheath.The finding was identified on (b)(6) 2022.It was initially reported by the customer that during the procedure, the catheter couldn¿t advance in the introducer due to the impediment.The second catheter was used to complete the operation.There was no report on adverse event on patient.Hemostatic valve separation is mdr-reportable.

• 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 ; 6465917981
• MDR Report Key: 14103832
• MDR Text Key: 289199421
• Report Number: 2029046-2022-00792
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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