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

Model Number D138502

Device Problems Obstruction of Flow (2423); Detachment of Device or Device Component (2907)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The biosense webster, inc.(bwi) product analysis lab received the device on 31-jan-2022.The device evaluation was completed on 24-feb-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 found dislodged inside of the hub of the vizigo¿.Sheath.The dilator was introduced with the hemostatic valve dislodged and resistance was found.Then, the hemostatic valve was taken off the hub and the dilator was introduced again and no resistance was found.Microscopic examination of the hemostatic valve surface showed evidence of damage to the outer diameter.Additionally, the silicon ring was not found inside the vizigo¿.A device history record review was performed for the finished device 00001519 number, and no internal actions related to the complaint were found during the review.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.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Due to the conditions observed in the hemostatic valve, an internal corrective action has been opened to investigate this issue.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and the biosense webster inc, (bwi) product analysis lab observed that the hemostatic valve was found dislodged inside the hub of the vizigo¿ sheath.Initially, it was reported that the dilator did not progress through the vizigo¿.No pressure was applied when they were trying to put the catheter into the sheath or when they were trying to withdraw it from the sheath.There was no physical damage observed on the sheath.There was no occlusion observed when irrigating the sheath.The sheath was not narrowed, partially blocked or completely blocked.The catheter was not able to move through the sheath.They have inserted the needle into the dilator.It is unknown if the surgery was delayed nor if it was successfully completed.No adverse patient consequences were reported.The obstructed sheath issue was assessed as not mdr reportable.There is evidence of a product malfunction, as the device failed to meet its performance specification or otherwise performed as intended, however the potential that it could cause or contribute to a death or serious injury, or other significant adverse event is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found that the hemostatic valve was dislodged inside of the hub of the vizigo¿.Sheath.This issue was assessed as a mdr reportable product malfunction.Therefore, the awareness date for this reportable lab finding is 24-feb-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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13876367
• MDR Text Key: 295812982
• Report Number: 2029046-2022-00617
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2022

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: 12/02/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2020
• 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