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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 ¿ MEDIUM; INTRODUCER, CATHETER

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BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM; INTRODUCER, CATHETER Back to Search Results
Model Number D138502
Device Problems Fluid/Blood Leak (1250); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone: (b)(6).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 leak occurred.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was inserted into the patient¿s body and that when the dilator was removed, blood leaked from the valve, so a replacement was performed.This occurred after it was inserted into the patient¿s body, during removal of the dilator.The procedure was completed by changing the sheath.Additional information was later received indicating there was no physical damage on the valve/hub.The hemostasis valve (gasket) did not break into two or more separate pieces.The hemostatic valve/brim cap/hub did not become detached from the sheath.Air did not enter the patient¿s body.This issue did not require percutaneous or surgical removal.Hemodynamics were not compromised due to bleeding.The approximate volume of blood lost was a few drops, but the exact amount is unknown.There was no medical intervention required to stop the bleeding.
 
Manufacturer Narrative
On 11-jan-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.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
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 leak occurred.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was inserted into the patient¿s body and that when the dilator was removed, blood leaked from the valve, so a replacement was performed.This occurred after it was inserted into the patient¿s body, during removal of the dilator.The procedure was completed by changing the sheath.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi then conducted a visual inspection of the returned device.Visual analysis of the returned device revealed that the hemostatic valve and the silicon ring were missing from the vizigo's hub.This finding has been reviewed and determined the issue of the hemostatic valve separation/missing is considered to be an mdr reportable malfunction.It should be noted that product failure is multifactorial.It could be determined that the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve.However, this cannot be conclusively determined.A device history record evaluation was performed for the finished device number, and no internal actions related to the complaint were found during the review.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.According to the odp (optimal performance guide), there are some precautions 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 additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
 
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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 Key13085932
MDR Text Key287583261
Report Number2029046-2021-02248
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016277
UDI-Public10846835016277
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/04/2022
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 Date06/12/2022
Device Model NumberD138502
Device Catalogue NumberD138502
Device Lot Number00001689
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/01/2021
Initial Date FDA Received12/26/2021
Supplement Dates Manufacturer Received01/11/2022
02/07/2022
Supplement Dates FDA Received02/01/2022
03/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
8.5F SHEATH WITH CURVE VIZ MDC; SOUNDSTAR ECO GE 8F CATHETER
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