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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 Entrapment of Device (1212); Device-Device Incompatibility (2919); Material Protrusion/Extrusion (2979); Patient Device Interaction Problem (4001)
Patient Problems Stroke/CVA (1770); Foreign Body In Patient (2687)
Event Date 07/25/2022
Event Type  Injury  
Event Description
It was reported that an unknown patient underwent a atrial fibrillation ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath - small. The patient suffered device entrapment, requiring surgical intervention; an electrode detached, and internal components were exposed. While putting the sheath into the patient, the hcp said, it is hard to insert the mandrain (needle). Then he got it. Post op, when the hcp wanted to pull out the sheath, it was stuck in the patient and it did not go out. Another doctor had to help; the sheath was stuck. When they were able to pull it out, fragments of the distal end were gone off, but were saved and out of the patient. The patient did not experience a post-op device malfunction. Other medical intervention was required, the wound ( access site) had to be enlarged, then it was sewn up, the patient is not part of a clinical study. There was a resistance between dilator and sheath. The doctor described it as an mandrain (he used this word for the needle). The resistance was between dilator and sheath. There was no occlusion when irrigating the sheath, and the doctor used it as normal. The sheath was narrowed. To remove the sheath, the doctor had to cut the body access about 2mm more at normal procedure. No special items were necessary. To remove the fragments nothing was needed. The one and only item came out alone by pulling the sheath. The damage resulted in outlayer wires being partially torn. The proximal electrode ring is lifted and detached. The detachment was total. The section removed from the sheath when it was pulled out of the patient and fell to the table. No patient consequences confirmed. Resistance with sheath is not mdr-reportable. Medical device entrapment with excessive manipulation required is mdr-reportable. Electrode damage resulting in sharp rough edges is mdr-reportable. Exposure of internal components is mdr-reportable. Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.
 
Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed. However, a picture was received for evaluation following biosense webster's procedures. Device investigation details: according to pictures provided by the customer, an electrode of the vizigo sheath was detached completely, this condition could be related to the manipulation of the device during the removal, since according to the additional information provided the sheath was narrowed and the only item came out alone by pulling the sheath. The damage resulted in outlayer wires being partially torn. The proximal electrode ring was lifted and detached. The detachment was total. A manufacturing record evaluation was performed for the finished device number 00001985 and no internal action related to the complaint was found during the review. The customer complaint was confirmed based on the picture received. The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence. 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 NameCARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL
Type of DeviceINTRODUCER, 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 Key15262543
MDR Text Key298282308
Report Number2029046-2022-01918
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016253
UDI-Public10846835016253
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD138501
Device Catalogue NumberD138501
Device Lot Number00001985
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/21/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/19/2022 Patient Sequence Number: 1
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