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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER? II; CARDIAC ABLATION PERCUTANEOUS CATHETER
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BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER? II; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Model Number M004EPT5031T0
Device Problems Entrapment of Device (1212); Kinked (1339); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2015
Event Type  malfunction  
Event Description
It was reported that the catheter folded on itself and removal difficulties were encountered.The patient was undergoing an ablation treatment for documented supraventricular tachycardia (svt).Two quadripolar fixed curve, one decapolar steerable cs catheter and one 7-110-2.5-7-4mm blazer¿ catheter were placed through hemostatic introducer sheaths.The blazer was placed in the left ventricle through the aorta.After some maneuvers to land on the ablation site, it was noted that the maestro 3000 generator produced a high impedance error.The catheter cable was changed, but the issue remained.When the catheter was removed from the patient, the distal segment was observed to be twisted in a helical shape.Another of the same catheter was then used.The second blazer catheter was then introduced to the patient through the 7f introducer sheath.While moving the catheter through the arteries, it folded in two.The physician drew it back a little to unfold it and went on with the procedure.The catheter folded in the same spot again in a different location in the aorta.The physician again drew the catheter back in an attempt to unfold it, but the catheter didn't unfold and got stuck to the introducer sheath with no response to handle manipulations.When the introducer sheath and the catheter were withdrawn from the patient together, the catheter was observed as bent and caused the introducer to ¿crash.¿ the procedure was not completed.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.:the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.  (b)(4).
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device has a severe kinked in the distal tip while in the neutral position.The steering knob and the tension control knob functioned properly on both lock and unlock positions.The right and the left curves do not meet the specification, the tip is not placed in the shaded region.The distal section was dissected finding the center support kinked.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was further reported that while the physician was trying to removed the catheter, it was noted that the distal segment of the catheter became caught on the tip of the non bsc introducer sheath causing it to collapse forming a bellow like shape.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that while the physician was trying to removed the catheter, it was noted that the distal segment of the catheter became caught on the tip of the non bsc introducer sheath causing it to collapse forming a bellow like shape.
 
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Brand Name
BLAZER? II
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
302 parkway
la aurora
heredia
CS 
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
302 parkway
la aurora
heredia
CS  
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4757647
MDR Text Key5783566
Report Number2134265-2015-03080
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
PMA/PMN Number
P920047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/25/2017
Device Model NumberM004EPT5031T0
Device Catalogue NumberEPT5031T
Device Lot Number16761452
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/16/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
II 7/110/2.5/7 BLAZER II - CATHETER; 7F INTRODUCER SHEATH; MAESTRO 3000- GENERATOR
Patient Age30 YR
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