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

Model Number D138502

Device Problems Material Separation (1562); Obstruction of Flow (2423); Material Deformation (2976)

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

Event Date 01/28/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium and a hemostatic valve separation issue occurred.It was reported that the vizigo¿ sheath dilator would not fit into the sheath.There was resistance when trying to put the dilator into the sheath.There was no damage upon opening but from trying to insert the dilator, the valve of the sheath was damaged, and kinks were in the dilator.When trying to flush the sheath, the irrigation back flowed out of the valve.There didn¿t appear to be anything inside the sheath occluding the dilator.It was unable to be advanced into the sheath.The sheath was replaced, and the issue resolved.No adverse patient consequence was reported.The obstructed ¿ sheath and dilator damage issues were assessed as not mdr reportable.The hemostatic valve separation was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 28-mar-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium (stsf) and a hemostatic valve separation issue occurred.It was reported that the vizigo¿ sheath dilator would not fit into the sheath.There was resistance when trying to put the dilator into the sheath.There was no damage upon opening but from trying to insert the dilator, the valve of the sheath was damaged, and kinks were in the dilator.When trying to flush the sheath, the irrigation back flowed out of the valve.There didn¿t appear to be anything inside the sheath occluding the dilator.It was unable to be advanced into the sheath.The sheath was replaced, and the issue resolved.No adverse patient consequence was reported.Device evaluation details: visual analysis revealed that the hemostatic valve was found dislodged inside the vizigo¿ sheath hub.Microscopic examination in 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.Also, the dilator and an stsf catheter were introduced into the vizigo¿ sheath (with no brim cap), and resistance was detected.The outer diameter of the dilator was measured, and it was within specifications.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, which is related to the resistance detected by the customer when it was tried to insert the dilator into the sheath.A device history record (dhr) evaluation was performed for the finished device [50000063] number, and no internal actions related to the reported complaint condition were identified.Based on the dhr, the h4.Device manufacture date has been updated.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.-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.This issue will be addressed through bwi's quality system.Explanation of codes: investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: cause not established (d15) / component code: device ingredient or reagent (g01003) were selected as related to the obstructed sheath issue.Investigation findings: fracture problem (c070603) / investigation conclusions: cause not established (d15)/ component code: valve(s) (g04135) were selected as related to the hemostatic valve separation issue.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the dilator damage.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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: 13592406
• MDR Text Key: 289887236
• Report Number: 2029046-2022-00372
• 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,Followup
• Report Date: 04/25/2022

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: 12/01/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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: UNK BRAND SHEATH.