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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); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ small and the biosense webster, inc. Product analysis lab observed a hemostatic valve separation issue. Initially it was reported that an occlusion / no irrigation issue occurred. It was reported that during the procedure, the device (including port, luer hub) was not irrigating. A second vizigo sheath was used to complete the procedure. There was no patient consequence reported. Additional information was received on the event. There was no resistance with sheath when they were trying to put the dilator into the sheath or when they were trying to withdraw it from the sheath. There was no physical damage on the sheath/dilator. There was total occlusion when irrigating the sheath. The sheath was not narrowed, partially blocked or completely blocked. The dilator was able to be moved through the sheath. The dilator was not stuck on the sheath. The event was assessed as not mdr reportable for an obstructed sheath issue. The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote. The biosense webster, inc. Product analysis lab received the device for evaluation and per the evaluation completion on 25-feb-2022 the hemostatic valve was not found on the hub component nor inside the sheath. The returned condition was assessed as mdr reportable for a hemostatic valve separation issue. The awareness date for this reportable lab finding was 25-feb-2022.
 
Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 12-jan-2022. The device evaluation was completed on 25-feb-2022. The product was returned to biosense webster for evaluation. Bwi conducted a visual inspection and functional test of the returned device. Visual analysis of the returned sheath revealed that the hemostatic valve was not found on the hub component nor inside the sheath. The irrigation test could not be performed since the hemostatic valve was not returned, however, the device was tested and leakage was found in the hub due to the lack of the valve, for that reason, no obstruction could be confirmed. A device history record evaluation was performed, and no internal actions related to the reported complaint condition were identified. Additional investigation was initiated to address the root cause for the resistance to sheath issues. (b)(4). 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
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key13861182
MDR Text Key290454160
Report Number2029046-2022-00556
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016253
UDI-Public10846835016253
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/03/2022
Device Model NumberD138501
Device Catalogue NumberD138501
Device Lot Number00001775
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2022
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/03/2021
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: 03/23/2022 Patient Sequence Number: 1
Treatment
UNK_CARTO VIZIGO SHEATH
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