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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Model Number M004PM4500N40
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/30/2015
Event Type  malfunction  
Manufacturer Narrative
Patient age: over 18 years old.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).
 
Event Description
It was reported that the wire was exposed.The lesion being treated was located in the right atrium.After using a intellatip mifi¿ xp temperature ablation catheter it was noted that the wire was exposed through the body of the catheter.The procedure was completed with this device and no patient complications were reported.The patient's status is okay.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that the target lesion was located in the right femoral vein.An 8 fr standard short sheath was switched out to 8.5 fr sro sheath.Rf application was administered.It was then noted under fluro that the device appeared to have a "duck bill" when trying to actuate to its asymmetric curve type.Additional fr application was administered.Once ablation was completed the device was successfully removed.
 
Manufacturer Narrative
Device evaluated by mfr: unit returned in a generic plastic bag.The unit returned has distal end damage, as part of overall visual revision.The returned device matches with upn provided by the customer.The device has a kink at 14mm from the tip while in the neutral position (between ring 1 and 2), the shaft is ripped at 16mm from the tip and the center support is broken protruding out the shaft.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
 
Event Description
It was further reported that the target lesion was located in the right femoral vein.An 8 fr standard short sheath was switched out to 8.5 fr sro sheath.Rf application was administered.It was then noted under fluro that the device appeared to have a "duck bill" when trying to actuate to its asymmetric curve type.Additional fr application was administered.Once ablation was completed the device was successfully removed.
 
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Brand Name
INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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 Key5185308
MDR Text Key29792722
Report Number2134265-2015-07488
Device Sequence Number1
Product Code OAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P020025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 09/30/2015
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 Date12/31/2017
Device Model NumberM004PM4500N40
Device Catalogue NumberPM4500N4
Device Lot Number0017499145
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/30/2015
Initial Date FDA Received10/28/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received11/19/2015
01/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number91104079-FA
Patient Sequence Number1
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