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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

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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 Break (1069); Material Twisted/Bent (2981); Mechanical Jam (2983); Torn Material (3024)
Patient Problem Tissue Damage (2104)
Event Date 06/14/2016
Event Type  malfunction  
Manufacturer Narrative
The bwi failure 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.(b)(4).
 
Event Description
It was reported that a patient underwent an atrial fibrillation procedure with a lasso navigational variable eco catheter.During the fast anatomical mapping in the left atrium, the catheter got stuck in the mitral valve.It took at least 6-7 minutes to remove it.They then saw some red tissue on it and the catheter was damaged between the loop and the shaft.There was no wires exposed.There were no lifted or sharp rings.The catheter was not pre-shaped.The 8f preface sheath was used.The patient did not have any symptoms but they were going to examine him further within the next hour.They lost approximately 15 minutes from the procedure.At the end, the patient was successfully ablated.The procedure was completed with no patient consequence.These issues were assessed as not reportable as they do not pose any risk to the patient.The tissue was present and noted during the procedure but the patient was free of symptoms or distress of any kind.The device was also removed without surgical intervention.Also per the additional information received, there were no wires exposed or lifted or sharp rings.Therefore, with the information available at the time, the catheter integrity was maintained.The biosense webster failure analysis lab received the catheter for analysis on july 6, 2016 and discovered that the spine was twisted, the outer cover of the catheter was torn and internal parts were exposed.Therefore, since the catheter integrity has been compromised, this returned catheter condition of the internal parts exposed has been assessed a reportable malfunction.
 
Manufacturer Narrative
(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a lasso navigational variable eco catheter.During the fast anatomical mapping in the left atrium, the catheter got stuck in the mitral valve.It took at least 6-7 minutes to remove it.They then saw some red tissue on it and the catheter was damaged between the loop and the shaft.There was no wires exposed.There were no lifted or sharp rings.The catheter was not pre-shaped.The 8f preface sheath was used.The patient did not have any symptoms but they were going to examine him further within the next hour.They lost approximately 15 minutes from the procedure.At the end, the patient was successfully ablated.The procedure was completed with no patient consequence.Upon receipt, the catheter was visually inspected and the spine was found twisted near the loop with internal parts exposed.The catheter outer diameters were measured and they were found within specifications.According to the event description lasso got stuck at the mitral valve and it took 6-7 minutes to be released; the catheter loop damages observed might be related to the efforts to disengage the catheter from the mitral valve.The instructions for use (ifu) states that in order to prevent entanglement of the catheter with the valves, care should be taken around the atrio-ventricular valve region.It is also stated that careful manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.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.The customer complaint has been verified.Based on available analysis results, the failure mode does not appear to be caused by any internal biosense webster, inc.Processes.The instructions for use (ifu) states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.
 
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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 Key5819013
MDR Text Key51232407
Report Number9673241-2016-00452
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeHU
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,Followup
Report Date 06/14/2016
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 Date03/31/2019
Device Model NumberD-1343-02-S
Device Catalogue NumberD134302
Device Lot Number17442012L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/14/2016
Initial Date FDA Received07/25/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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