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

Model Number D138502

Device Problems Complete Blockage (1094); Material Separation (1562); Obstruction of Flow (2423)

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

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

On 4-aug-2022, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation occurred.While using the introducer to advance the ablation catheter into the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, it felt like it became "stuck." the bwi representative reported that when aspirating only air was coming through.The introducer was removed, and it was noticed that the introducer seemed to be "too large" as it became "pinched" and buckled on itself.The hemostatic valve was pushed in as well.The vizigo sheath was replaced, and the issue resolved.The procedure continued.Additional information received indicated the hemostasis valve (gasket) did not break into two or more separate pieces.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was being used on the patient at the time of incident but air did not enter the patient¿s body.This issue did not require percutaneous, surgical removal or medical intervention.Blood return was observed and the approximate volume of blood that was lost was 1ml.Patient hemodynamics were not compromised due to bleeding.There was occlusion when irrigating the sheath and it was described the sheath partially blocked.They were inserting the catheter into the sheath.

Manufacturer Narrative

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 occurred.While using the introducer to advance the ablation catheter into the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, it felt like it became "stuck." the bwi representative reported that when aspirating only air was coming through.The introducer was removed, and it was noticed that the introducer seemed to be "too large" as it became "pinched" and buckled on itself.The hemostatic valve was pushed in as well.The vizigo sheath was replaced, and the issue resolved.The procedure continued.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual and dimensional inspection and irrigation test of the returned device were performed following bwi procedures.Visual analysis revealed that the hemostatic valve was dislodged and broken inside the hub component, no other damage on the sheath or the dilator were observed.The stress marks suggest that excessive force or manipulation was applied due to an extreme off axis angle of insertion.Valve dislodgement occurs when extreme off axis angles are performed during insertion with the dilator, outside of what is recommended in the odp (optimal device performance guide).The device was connected to a syringe with water and irrigation could be performed but leakage was observed from the valve area.The dilator and a good known lab sample catheter were introduced through the sheath, and no obstruction or resistance was felt.The dilators outer diameter was measured, and dimensions were found within specifications.It was determined that the occlusion/no irrigation issue described by the customer could be related to the hemostatic valve failure detected during this investigation.A device history record was performed for the finished device batch number, and no internal actions were identified.The hemostatic valve and irrigation issues reported by the customer were confirmed; however, the obstruction issue could not be replicated.The odp 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: unintended use error caused or contributed to event (d1102) / component code: valve(s) (g04135) were selected as related to hemosttaic valve separation the occlusion issues reported by the customer.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the reported obstruction issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).On 18-jan-2023, the following correction/clarification were processed under the product evaluation details.It was clarified that a visual microscopic examination was performed which revealed the hemostatic valve was placed in its original place and actually broken in the star section of the valve.Hemostatic valve piece was partially detached.Due to this finding, internal action has been initiated to further investigate the findings.The hemostatic valve issue reported by the customer was confirmed; however, the obstruction and no irrigation issues could not be replicated.

• 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: 15221493
• MDR Text Key: 305081020
• Report Number: 2029046-2022-01862
• 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,Followup,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• 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: CARTO 3 SYSTEM; UNKNOWN ABLATION CATHETER; UNK_PENTARAY