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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 - MEDIUM INTRODUCER, CATHETER

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BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER Back to Search Results
Model Number D138502
Device Problems Material Separation (1562); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  malfunction  
Manufacturer Narrative
Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed. Bwi then conducted a visual inspection and microscopic examination of the returned device. Visual analysis of the returned sample revealed that the hemostatic valve was found dislodged inside of hub of the vizigo sheath. Microscopic examination in the hemostatic valve surface and showed evidence of stress marks on the outer diameter. The brim cap and the silicone ring were placed in the correct position and found in good conditions. The hemostatic valve condition can be related to the occlusion issue experiences by the customer. It should be noted that product failure is multifactorial. The issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve. The stress marks, and physical damage observed suggest that excessive force was applied. 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. ¿ as part of the quality process, all devices are manufactured, inspected, and released to approved specifications. However, due to the conditions observed in the hemostatic valve, an internal corrective action has been opened 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).
 
Event Description
A patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath - medium for which biosense webster¿s product analysis lab (pal) identified a hemostatic valve separation. It was initially reported by the customer that the dilator of the viziogo sheath would not advance into the sheath. The sheath was exchanged and the issue was resolved. The case continued without any further incident. There was no patient consequence. The issue was felt while trying to insert the dilarto into the sheath. The carto vizigo¿ 8. 5f bi-directional guiding sheath - medium appeared to be partially blocked as they could not move the dilator through the sheath, however, there was no occlusion when irrigating the sheath. This issue of obstructed sheath is not considered to be an mdr reportable event 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 (b)(6) 2022, pal revealed that a visual inspection of the returned complaint device found that the hemostatic valve was found dislodged inside of hub of the vizigo sheath. This finding has been reviewed and determined to be an mdr reportable malfunction.
 
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Brand NameCARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM
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 Key13926234
MDR Text Key288485659
Report Number2029046-2022-00640
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016277
UDI-Public10846835016277
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
Type of Report Initial
Report Date 03/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD138502
Device Catalogue NumberD138502
Device Lot Number50000054
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2022
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2021
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: 03/28/2022 Patient Sequence Number: 1
Treatment
8.5F SHEATH WITH CURVE VIZ MDC
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