• 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. (JUAREZ) LASSO® 2515 NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

  • 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. (JUAREZ) LASSO® 2515 NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number D-1343-02-S
Device Problems Device Packaging Compromised (2916); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2017
Event Type  malfunction  
Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer's ref.No: (b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a lasso nav variable eco catheter where the outer surface of the catheter became compromised.When inserting the catheter into the introducer, the external surface of the catheter started to tear.The issue was noticed immediately, and the catheter was replaced with another.The case was finished without any patient consequences.It is not known if there was difficulty maneuvering the catheter, or what exactly caused the tearing of the external surface of the catheter.Multiple attempts have been made to obtain additional information regarding this complaint, but none has been made available.If the catheter is almost splitting/detaching or internal components are exposed, the risk to the patient is critical due to the potential of thrombus formation.As a result, this event is mdr reportable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LASSO® 2515 NAV ECO VARIABLE CATHETER
Type of Device
CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BIOSENSE WEBSTER, INC. (JUAREZ)
circuito interior norte #1820
parque industrial salvacar
juarez, chihuahua 32599
MX  32599
Manufacturer (Section G)
BIOSENSE WEBSTER, INC. (JUAREZ)
circuito interior norte #1820
parque industrial salvacar
juarez, chihuahua 32599
MX   32599
Manufacturer Contact
joaquin kurz
33 technology drive
irvine, CA 92618
9497893837
MDR Report Key6541733
MDR Text Key74515075
Report Number9673241-2017-00338
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K113213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 04/12/2017
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 Date12/31/2019
Device Model NumberD-1343-02-S
Device Catalogue NumberD134302
Device Lot Number17624872L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/10/2017
Initial Date FDA Received05/03/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/06/2017
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
-
-