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); Material Integrity Problem (2978)

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

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The product investigation was completed.Device evaluation details: visual analysis revealed that the hemostatic valve was dislodged inside of hub component.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 causing the dislodgment of the valve; the stress marks and physical damage observed suggest that excessive force or manipulation was applied; however, this could not be conclusively determined.Due to the conditions of the hemostatic valve, an internal action was opened.A device history record was performed for the finished device (b)(4) number, and no internal actions related to the complaint were found during the review.The issue reported by the customer was 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.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 for which biosense webster¿s product analysis lab identified that the hemostatic valve was found dislodged inside the hub component.The finding was identified on (b)(6) 2022.It was reported during dilator insertion that the hemostatic valve fell into the valve (since it was not attended and before confirmation of the product with complaint, it was described after confirmation.).The valve did not drop into the patient's body.The hemostatic valve was intact.The sheath was replaced.The procedure was completed without patient's consequence.Hemostatic valve separation is mdr-reportable.Hemostatic valve damage (from the initial procedure) is not mdr-reportable.Obstructed sheath is not 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 ; 646591-798
• MDR Report Key: 14599650
• MDR Text Key: 293340843
• Report Number: 2029046-2022-01198
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/05/2022

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: 10/23/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2021
• 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
• Treatment: THERMOCOOL SMARTTOUCH; UNSPECIFIED GENERATOR