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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 01/07/2022
Event Type  malfunction  
Manufacturer Narrative
The biosense webster, inc. (bwi) product analysis lab received the device on 09-feb-2022. The device evaluation was completed on (b)(6) 2022. Bwi then conducted a visual inspection and microscopic examination of the returned device. Visual analysis of the returned carto vizigo sheath sample revealed that the hemostatic valve was found dislodged inside of the hub and the vizigo shaft was bent. Microscopic examination of the hemostatic valve surface showed evidence of stress marks on the outer diameter. On the other hand, the brim cap and the silicone ring were placed in the correct position and found in good conditions. A device history record evaluation was performed for the finished device number 00001686 and no internal action was found during the review. 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. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that a patient underwent an atrial flutter right (r-afl) ablation 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 found dislodged inside of the hub initially, it was reported that the valve to flush would not flush properly and was leaking. It was being flushed to prep it and it would not flush down the sheath. The port was broken in some way to not allow it to. The side port was the issue. When trying to flush the side port, it would not flush and was leaking through the port. The catheter was not in the patient¿s body. The issue was resolved by replacing the sheath 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 revealed that the hemostatic valve was found dislodged inside of the hub and the vizigo¿ shaft was bent. Microscopic examination in the hemostatic valve surface and showed evidence of stress marks on the outer diameter. This was assessed as mdr reportable. Therefore, the awareness date for this reportable lab finding is (b)(6) 2022.
 
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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
6465917981
MDR Report Key13983008
MDR Text Key290971419
Report Number2029046-2022-00702
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 04/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/11/2022
Device Model NumberD138501
Device Catalogue NumberD138501
Device Lot Number00001686
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2022
Date Manufacturer Received03/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2021
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: 04/01/2022 Patient Sequence Number: 1
Treatment
UNK BRAND SHEATH
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