• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER Back to Search Results
Model Number D138502
Device Problems Obstruction of Flow (2423); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned to biosense webster inc. (bwi) for evaluation. 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 the hub of the vizigo¿ sheath. Also, the vessel dilator was bent. A functional test was performed, in accordance with bwi procedures. The vessel dilator and stsf catheter were introduced into the vizigo¿ sheath and no resistance was detected. The outer diameter (od) vessel dilator was measured, and it was within specifications. 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 [50000032] number, and no internal actions related to the reported complaint condition were identified. It should be noted that product failure is multifactorial. It was determined that 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 the physical damage observed in the dilator suggest that excessive force was applied. The hemostatic valve dislodgement could be related to the resistance detected by the customer. According to the odp (optimal performance guide), there are some precautions and recommendations 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. Prior to inserting the device into the patient, pre-assemble sheath, dilator, and stylet on the table. Advance the needle through the dilator and check for excessive resistance as the tip of the needle advances through the curvature of the sheath/dilator assembly. If resistance is encountered, do not use excessive force to advance or withdraw the catheter through the sheath. As part of the quality process, all devices are manufactured, inspected, and released to approved specifications. Due to the condition observed regarding the hemostatic valve, an internal corrective action has been opened to investigate this issue. (b)(4). 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 fibrillation (afib) procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath - medium and the biosense webster inc, (bwi) product analysis lab observed that the hemostatic valve was found dislodged inside the hub of the vizigo¿ sheath. Initially, it was reported that the dilator of the vizigo¿ would not advance into the sheath. The caller stated that the dilator appeared to be bent. The sheath was exchanged and the issue was resolved, the case continued without any further incident. No adverse patient consequences were reported. The 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. The dilator damage was assessed as not mdr reportable. 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 dislodged inside the hub of the vizigo¿ sheath. This was assessed as mdr reportable. Therefore, the awareness date for this reportable lab finding is 21-feb-2022.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13853059
MDR Text Key290454243
Report Number2029046-2022-00591
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 03/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/07/2022
Device Model NumberD138502
Device Catalogue NumberD138502
Device Lot Number50000032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2022
Date Manufacturer Received02/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2021
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: 03/22/2022 Patient Sequence Number: 1
Treatment
7FR DECAN,11P,F,2.4MMLE,282MM,; UNK BRAND CABLE; UNK BRAND CATHETER; UNK BRAND SHEATH
-
-