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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 ¿ LARGE INTRODUCER, CATHETER

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BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE INTRODUCER, CATHETER Back to Search Results
Model Number D138503
Device Problems Material Separation (1562); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
A patient underwent a cardiac ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ large for which biosense webster¿s product analysis lab (pal) identified a hemostatic valve separation. It was initially reported by the customer that it was not possible to put the dilator into the carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ large. There was resistance with putting it in and not possible to move it through. The sheath was not irrigated because the dilator could not be used. There was no physical damage on the sheath/dilator. There was no patient consequence. The customer¿s reported obstructed sheath issue is not mdr reportable since there is evidence of a product malfunction, as the device failed to meet its performance specification or otherwise performed as intended, however the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote. On 31-jan-2022, pal revealed that a visual inspection of the device found hemostatic valve was not returned with the carto vizigo sheath. This finding of hemostatic valve separation is considered to be an mdr reportable malfunction. This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 31-jan-2022 and reassessed it as mdr reportable.
 
Manufacturer Narrative
Device evaluation details: the product was returned to biosense webster inc. (bwi) for evaluation and the evaluation has been completed. Bwi then conducted a visual inspection of the returned sheath. Visual analysis of the returned sample revealed that the hemostatic valve was not returned with the carto vizigo sheath. A device history record evaluation was performed, and no internal actions were identified. It should be noted that sheath failure is multifactorial. Based on the information currently available, the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve and silicone ring. The dilator was inserted to verify if the valve was inside the sheath, but it was not found. 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. ¿. Note: the event date is unknown, as such, the date of event has been populated to (b)(6) 2021. 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 NameCARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE
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 Key13596814
MDR Text Key289887189
Report Number2029046-2022-00379
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016260
UDI-Public10846835016260
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/12/2022
Device Model NumberD138503
Device Catalogue NumberD138503
Device Lot Number00001656
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2021
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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