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)

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

Event Date 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, a picture(s) were provided by the customer.Evaluation is still in progress.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 ref.# (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve detachment occurred.It was reported there was a defect on the diaphragm at the dilator insertion part.The white ring /gasket was inside the vizigo handle.The hemostatic valve looked deformed.There was resistance when they were trying to put the catheter into the sheath.There was no occlusion when irrigating the sheath, however, the sheath was completely blocked since the catheter was not still able to be moved through the sheath.They were inserting the dilator into the sheath.This was identified before the case.The sheath was not being used on the patient; the issue was recognized before being used.Air did not enter the patient¿s body.This issue did not require percutaneous or surgical removal.Blood return was not observed.There were no wires being exposed or any lifted or sharp rings.The sheath was replaced and the issue resolved.The carto 3 system is operating per specs and is not responsible for the product issue.

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve detachment occurred.It was reported there was a defect on the diaphragm at the dilator insertion part.The white ring /gasket was inside the vizigo handle.The hemostatic valve looked deformed.There was resistance when they were trying to put the catheter into the sheath.There was no occlusion when irrigating the sheath, however, the sheath was completely blocked since the catheter was not still able to be moved through the sheath.They were inserting the dilator into the sheath.This was identified before the case.The sheath was not being used on the patient; the issue was recognized before being used.Device evaluation details: on 21-apr-2022, the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and microscopic examination of the returned device were performed following bwi procedures.Visual analysis revealed that the hemostatic valve was dislodged inside of hub component, also, no damage or anomalies on the sheath and the dilator.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.The dilator and a good known lab sample catheter were introduced through the sheath, and resistance was felt.No obstructions were detected.The dilator outer diameter was measured, and dimensions were found within specifications.Additionally, the customer provided a picture of the complaint device to aid in the product investigation.Based on the picture provided by the customer, the hemostatic valve was dislodged inside the hub component.Due to the conditions observed in the hemostatic valve, an internal corrective action has been opened to address this issue.A device history record was performed for the finished device batch number, and no internal actions were identified.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.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: 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: material and/or chemical problem identified (c06) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112) were selected as related to the obstructed sheath.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 13936049
• MDR Text Key: 290455129
• Report Number: 2029046-2022-00662
• 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: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2021
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; CARTO 3 SYSTEM