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

Model Number D138502

Device Problem Obstruction of Flow (2423)

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

Event Date 05/26/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2022.The device evaluation was completed on (b)(6) 2022.The product was returned to biosense webster for evaluation.Bwi then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the hemostatic valve was dislodged inside the hub of the carto vizigo sheath.The valve separation could be related to the experienced obstruction.Examination of the shaft, the dilator, the brim cap, and the silicone ring revealed the components were placed in the correct position and found in good conditions.The functional test was performed, in accordance with biosense webster, inc.Procedures.After the hemostatic valve removal, the vessel dilator and smarttouch sf catheter were introduced into the vizigo sheath and no resistance was felt during the testing.The outer diameter vessel dilator was measured and it was within specifications.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 evaluation was performed, and no internal actions related to the reported complaint condition were identified.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium and the biosense webster, inc.Product analysis lab observed a hemostatic valve separation issue.Initially, the dilator was unable to be advanced into the carto vizigo¿ 8.5f bi-directional guiding sheath - medium.The sheath was replaced and the issue resolved.There was no patient consequence reported.Additional information was received on the event.They met resistance while inserting the dilator into the sheath.There was no visible occlusion.The event was assessed as not mdr reportable for an obstructed sheath issue.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 25-jul-2022 the hemostatic valve was dislodged inside the hub of the carto vizigo sheath.The returned condition was assessed as mdr reportable for a hemostatic valve separation issue.The awareness date for this reportable lab finding was (b)(6) 2022.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15246965
• MDR Text Key: 305504052
• Report Number: 2029046-2022-01905
• 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
• Type of Report: Initial
• Report Date: 08/17/2022

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: 03/20/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2022
• 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: UNKNOWN BRAND SHEATH