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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ULTRA ICE PLUS¿ CATHETER, ULTRASOUND, INTRACARDIAC

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) ULTRA ICE PLUS¿ CATHETER, ULTRASOUND, INTRACARDIAC Back to Search Results
Model Number M00499100
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/22/2018
Event Type  malfunction  
Manufacturer Narrative
It is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
It was reported that a catheter break / detachment occurred. An ultra ice plus ultrasound imaging catheter and another manufacturer¿s snare were selected for use during an implantable cardioverter defibrillator (icd) lead extraction procedure in the right atrium. During a twisting maneuver with the snare retrieval device, the catheter was entrapped while it was rotating and therefore became damaged. During retrieval of the devices, the piezoelectric crystal broke and detached from the catheter body. It was noted the detachment ¿probably¿ occurred inside the sheath. All components were removed from the patient without problems and the procedure was completed using a different device. There were no patient complications.
 
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Brand NameULTRA ICE PLUS¿
Type of DeviceCATHETER, ULTRASOUND, INTRACARDIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7341241
MDR Text Key102592786
Report Number2134265-2018-01975
Device Sequence Number1
Product Code DXK
UDI-Device Identifier08714729904373
UDI-Public08714729904373
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K160173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/05/2019
Device Model NumberM00499100
Device Catalogue Number9910
Device Lot Number20607150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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