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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE; INTRODUCER, CATHETER Back to Search Results
Model Number D138503
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2022
Event Type  malfunction  
Manufacturer Narrative
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.Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and a hemostatic valve separation issue occurred.The valve of the vizigo¿ sheath broke after inserting the dilator and as a result of this, they had bleed back out of the valve onto the table.They continued to use the product for 5 minutes but then the procedure ended.The event happened during the procedure.The product was not being used in a clinical trial.There was no patient impact, and the procedure was not extended greater than 30 minutes due to the failure.The brim cap/hub did not become detached from the sheath.The sheath was being used on the patient.Air entered the patient¿s body but there were no patient consequences, therefore, no treatment was required.The approximate volume of blood that was lost was negligible.The hemostatic valve separation issue was assessed as mdr reportable.
 
Manufacturer Narrative
The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 08-nov-2022.The device evaluation was completed on 14-nov-2022.It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and a hemostatic valve separation issue occurred.The valve of the vizigo¿ sheath broke after inserting the dilator and as a result of this, they had bleed back out of the valve onto the table.They continued to use the product for 5 minutes but then the procedure ended.The event happened during the procedure.The product was not being used in a clinical trial.There was no patient impact, and the procedure was not extended greater than 30 minutes due to the failure.The brim cap/hub did not become detached from the sheath.The sheath was being used on the patient.Air entered the patient¿s body but there were no patient consequences, therefore, no treatment was required.The approximate volume of blood that was lost was negligible.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, the hemostatic valve was dislodged inside the hub component.The issue reported by the customer was confirmed based on the picture received.The product was returned to biosense webster (bwi) for evaluation.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.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.A device history record evaluation was performed for lot 00001944 and no internal actions related to the complaint were found during the review.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.This product issue will be addressed through bwi's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
 
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Brand Name
CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE
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 Key15472513
MDR Text Key306331262
Report Number2029046-2022-02291
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016260
UDI-Public10846835016260
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/07/2022
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 Date03/20/2023
Device Model NumberD138503
Device Catalogue NumberD138503
Device Lot Number00001944
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/26/2022
Initial Date FDA Received09/23/2022
Supplement Dates Manufacturer Received11/08/2022
Supplement Dates FDA Received12/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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