• 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 Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2020
Event Type  malfunction  
Manufacturer Narrative
The product analysis has begun but is not completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. A device history record evaluation was performed for the finished device (b)(4)number, and no internal action was found during the review. 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
It was reported a patient underwent a cardiac ablation procedure for paroxysmal atrial fibrillation (afib) with a carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation and brim cap detachment issue occurred. During the procedure, the hemostatic valve of the carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ medium became detached, and there was back bleeding (5-10ml). The physician was able to stabilize it then exchange the carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ medium to continue the case successfully. Patient¿s hemodynamics was not compromised due to the issue experienced. No intervention was required to stop the bleed, therefore this will not be considered a patient adverse event but a product malfunction. On 12/23/2020, the bwi product analysis lab received the complaint device for evaluation. Visual inspection found the brim cap was found detached in the dilator. The hemostatic valve and friction ring were not returned. No cracks were observed on brim cap. These findings were reviewed and determined the brim cap detachment is also considered to be an mdr reportable malfunction.
 
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.
33 technology drive
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER INC (IRVINE)
33 technology drive
irivine CA 92618
Manufacturer Contact
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key11101278
MDR Text Key251099871
Report Number2029046-2020-02036
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,Followup
Report Date 12/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/08/2021
Device Model NumberD138502
Device Catalogue NumberD138502
Device Lot Number00001081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-