• 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 ¿ LARGE; 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 ¿ LARGE; INTRODUCER, CATHETER Back to Search Results
Model Number D138503
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2022
Event Type  malfunction  
Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 an unknown patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large.The hemostatic valve did not look as it should and was leaking.The valve of the vizigo sheath did not work properly causing bleed back.The sheath was replaced and the case continued.The hemostasis valve (gasket) did not dislodge inside or outside the hub.The brim cap/hub did not become detached from the sheath.Picture unavailable.The sheath was being used on the patient.Air did not enter the patient¿s body.The approximate volume of blood that was lost was less than 10ml, very minimal as it was replaced as soon as it was noticed the valve did not look as it should.Hemostatic valve separation is mdr-reportable.
 
Manufacturer Narrative
On 14-oct-2022, the product investigation was completed.It was reported that an unknown patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large.The hemostatic valve did not look as it should and was leaking.Device evaluation details: visual analysis of the returned sample revealed that no damage was observed.The returned sample was connected to a syringe with water and no leakage was observed.Then the functional test of the side port was performed, and no issues were observed.A device history record evaluation was performed for finished device number 00001988, and no internal actions related to the complaint were found during the review.The instructions for use contain the following warning stated in the instructions for use (ifu): before inserting the sheath into the patient, flush the sheath and dilator with heparinized normal saline to remove air bubbles and any potential particulate.After the sheath is in the left atrium of the patient, maintain a constant flow of heparinized normal saline to the sheath to minimize the risk of air emboli.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
 
Manufacturer Narrative
On 23-sep-2022, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE
Type of Device
INTRODUCER, 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
646591-798
MDR Report Key15460503
MDR Text Key306175270
Report Number2029046-2022-02282
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016260
UDI-Public10846835016260
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 Health Professional
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/11/2023
Device Model NumberD138503
Device Catalogue NumberD138503
Device Lot Number00001988
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/02/2022
Initial Date FDA Received09/21/2022
Supplement Dates Manufacturer Received09/23/2022
10/14/2022
Supplement Dates FDA Received10/10/2022
11/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-