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

Model Number D138502

Device Problem Partial Blockage (1065)

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

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and an irrigation inadequate sheath issue occurred.Airlock could not be flushed once the catheter was inserted.No patient consequences.Additional information was received.It was no irrigation error.The sheath could not be irrigated by hand.The physician did not feel resistance between the catheter and the sheath, not more as usual.They changed the sheath.Smarttouch sf was the catheter used.There was no damage on sheath/dilator due to the obstructed sheath.There was no occlusion when irrigating the sheath.They did not find any material causing the obstruction.The event was assessed as mdr reportable for an irrigation inadequate sheath issue.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 20-mar-2023, a correction was noted to the 3500a follow-up #2 as it should have stated the date of 21-feb-2023 instead of 22-feb-2023: "the biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 21-feb-2023, the hemostatic valve had a little piece broken.The returned condition was assessed as mdr reportable for a hemostatic valve separation issue.The awareness date for this reportable lab finding was 21-feb-2023.".

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation 23-jan-2023.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

It was reported that a patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and an irrigation inadequate sheath issue occurred.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 22-feb-2023, the hemostatic valve had a little piece broken.The returned condition was assessed as mdr reportable for a hemostatic valve separation issue.The awareness date for this reportable lab finding was 22-feb-2023.The device evaluation was completed on 21-feb-2023.The product involved: carto vizigo sheath.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection, backpressure test, and microscopic analysis of the returned device were performed following bwi procedures.Visual analysis revealed vessel dilator kinked, and the hemostatic valve with a little piece broken.A microscopic examination of the hemostatic valve surface also 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 broke 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.Flow and pressure tests failed due to the mentioned condition.No occlusions were detected when the device was flushed.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.Product failure is multifactorial.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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 the customer¿s reported ¿irrigation inadequate-sheath¿ issue and the biosense webster inc.Analysis finding of the ¿hemostatic valve separation¿ issue.-investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: guide (g04061) were selected as related to the biosense webster inc.Analysis finding of the ¿dilator shaft bent¿ issue.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) in the 3500a follow-up #2, it was reported: ¿the biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 21-feb-2023, the hemostatic valve had a little piece broken.The returned condition was assessed as mdr reportable for a hemostatic valve separation issue.The awareness date for this reportable lab finding was 21-feb-2023.¿ on 25-jul-2023, the product investigation was reopened to clarify/correct that the returned condition was assessed as mdr reportable for a hemostatic valve broken issue.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16043582
• MDR Text Key: 308470904
• Report Number: 2029046-2022-03240
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 60000021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2022
• 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: SMARTTOUCH SF CATHETER.; UNKNOWN BRAND SHEATH.