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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 Obstruction of Flow (2423); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2021
Event Type  malfunction  
Event Description
It was reported that a patient underwent an atrial flutter right (r-afl) procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath - small and the biosense webster inc, (bwi) product analysis lab observed that the hemostatic valve was not found on the hub component nor inside the sheath. Initially, it was reported that the dilator of the vizigo¿ sheath could not pass through the sheath. The caller stated that it stopped being able to advance about halfway through the sheath. The sheath was replaced, and the issue was resolved, and the procedure was continued. No adverse patient consequences were reported. The issue of obstructed sheath was assessed as not mdr reportable. 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. This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found that the hemostatic valve was not found on the hub component nor inside the sheath. This was assessed as mdr reportable. Therefore, the awareness date for this reportable lab finding is 09-feb-2022.
 
Manufacturer Narrative
The product was returned to biosense webster inc. (bwi) 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. In addition, some bents were observed on the vessel dilator. A functional test was performed, in accordance with bwi procedures. The vessel dilator and stsf catheter were introduced into the vizigo sheath and some resistance was felt during the testing. The od vessel dilator was measured, and it was within specifications. A device history record evaluation was performed for the finished device number 00001837 and no internal action was found during the review. As part of the quality process, all devices are manufactured, inspected, and released to approved specifications. 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. At this time it is not possible to determine the root cause of the hemostatic valve condition, however, based on the information provided, the condition reported has origin in someplace external to the manufacturing environment. Additional investigation was initiated to address the root cause for the resistance to sheath issues. 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 Key13692038
MDR Text Key290469145
Report Number2029046-2022-00482
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016253
UDI-Public10846835016253
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 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD138501
Device Catalogue NumberD138501
Device Lot Number00001837
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2022
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2021
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: 03/08/2022 Patient Sequence Number: 1
Treatment
UNK BRAND SHEATH
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