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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 ¿ SMALL; INTRODUCER, CATHETER
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BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL; INTRODUCER, CATHETER Back to Search Results
Model Number D138501
Device Problems Material Separation (1562); Device Contamination with Body Fluid (2317)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2022
Event Type  malfunction  
Manufacturer Narrative
On 13-apr-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).
 
Event Description
It was reported that a patient underwent an atrial flutter right (r-afl) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a hemostatic valve separation occurred.It was reported that the hemostatic valve of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small broke when the dilator was removed.The sheath was exchanged, and the issue was resolved, the case continued.Additional information was received indicating blood was seen coming from the location of the hemostatic valve upon removing the dilator.The hemostatic valve damage could not be visualized as the valve was obscured by clot.The valve did not become detached from the sheath.It is undetermined if air entered the patient¿s body.This issue did not require percutaneous or surgical removal.The patient¿s hemodynamics were not compromised due to bleeding.The approximate volume of blood that was lost was greater than 30ml.No medical intervention was required to stop the bleeding.Additional clarification provided regarding statement of the valve being obscured by clot; it appeared to be a clot as it did not move upon inspecting the catheter.They did not physically touch the valve to distinguish it.The sheath was set aside for some time before they inspected it, so they cannot say for sure if it was clotted from the time of incident or if clot formed while it sat aside.This was a typical flutter and they do not recall the patient being heparinized.No neurological effects were reported.
 
Manufacturer Narrative
It was reported that a patient underwent an atrial flutter right (r-afl) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a hemostatic valve separation occurred.It was reported that the hemostatic valve of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small broke when the dilator was removed.The sheath was exchanged, and the issue was resolved, the case continued.Additional information was received indicating blood was seen coming from the location of the hemostatic valve upon removing the dilator.The hemostatic valve damage could not be visualized as the valve was obscured by clot.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been complete.Visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed that the hemostatic valve was not found inside the device.The hemostatic valve detachment could be related to the dilator wrongly introduced; however, this could not be conclusively determined.Thrombus was not observed.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.This product issue will be addressed through bwi's quality system.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the thrombus/clot issue.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.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 ¿ SMALL
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
6465917981
MDR Report Key14139655
MDR Text Key290456406
Report Number2029046-2022-00844
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016253
UDI-Public10846835016253
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/02/2022
Device Model NumberD138501
Device Catalogue NumberD138501
Device Lot Number00001837
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received05/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2021
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 SMC; CARTO 3 SYSTEM; SOUNDSTAR ECO GE 8F CATHETER
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