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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 Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small where hemostatic valve separation occurred.When the dilator was inserted during the transseptal, it felt stranger hardness than during normal use, and once the dilator was pulled out, damage to the hemostatic valve was confirmed.It was confirmed after the procedure that the hemostatic valve had come off.The sheath was being used on the patient at the time of the event.No air entered the patient¿s body.
 
Manufacturer Narrative
On(b)(6) 2021, 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 cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small where hemostatic valve separation occurred.When the dilator was inserted during the transseptal, it felt stranger hardness than during normal use, and once the dilator was pulled out, damage to the hemostatic valve was confirmed.It was confirmed after the procedure that the hemostatic valve had come off.Device evaluation details: the device evaluation has been completed.A visual inspection was performed and it was found that the hemostatic valve is dislodged inside the hub of the device.It was determined that the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve since stress marks and physical damage on the outer diameter were observed under microscope which suggest that excessive force was applied.This retuned condition was reviewed and determined it continues to be deemed mdr reportable.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.A device history record was performed and no non-conformances related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the dislodged hemostatic valve inside the hub could be related to handling of the device during the procedure however, this cannot be conclusively determined.The odp (optimal device performance guide) provide additional instructions on how to insert the dilator into the sheath.Due to the conditions observed in the hemostatic valve, an internal corrective action has been open to address this 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.
33 technology drive
irvine CA 92618
MDR Report Key11099758
MDR Text Key251102993
Report Number2029046-2020-02026
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016253
UDI-Public10846835016253
Combination Product (y/n)N
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/27/2021
Device Model NumberD138501
Device Catalogue NumberD138501
Device Lot Number00001433
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Date Manufacturer Received01/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8.5F SHEATH WITH CURVE VIZ SMC
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