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); Material Deformation (2976)

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

Event Date 01/23/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to biosense webster inc.(bwi) 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 the hub of the vizigo¿ sheath.Also, the vessel dilator was bent.A functional test was performed, in accordance with bwi procedures.The vessel dilator and stsf catheter were introduced into the vizigo¿ sheath and no resistance was detected.The outer diameter (od) vessel dilator was measured, and it was within specifications.Microscopic examination of 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.A device history record evaluation was performed for the finished device [50000032] number, and no internal actions related to the reported complaint condition were identified.It should be noted that product failure is multifactorial.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 the physical damage observed in the dilator suggest that excessive force was applied.The hemostatic valve dislodgement could be related to the resistance detected by the customer.According to the odp (optimal performance guide), there are some precautions and recommendations 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.Prior to inserting the device into the patient, pre-assemble sheath, dilator, and stylet on the table.Advance the needle through the dilator and check for excessive resistance as the tip of the needle advances through the curvature of the sheath/dilator assembly.If resistance is encountered, do not use excessive force to advance or withdraw the catheter through the sheath.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Due to the condition observed regarding the hemostatic valve, an internal corrective action has been opened to investigate this issue.(b)(4).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

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, (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 of the vizigo¿ would not advance into the sheath.The caller stated that the dilator appeared to be bent.The sheath was exchanged and the issue was resolved, the case continued without any further incident.No adverse patient consequences were reported.The obstructed sheath 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.The dilator damage was assessed as not mdr reportable.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 the hub of the vizigo¿ sheath.This was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is 21-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: 13853059
• MDR Text Key: 290454243
• Report Number: 2029046-2022-00591
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• 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: 01/14/2022
• Date Manufacturer Received: 02/21/2022
• 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
• Treatment: 7FR DECAN,11P,F,2.4MMLE,282MM,; UNK BRAND CABLE; UNK BRAND CATHETER; UNK BRAND SHEATH