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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 M00499120
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis. Device analysis revealed that the transducer distal housing was found detached from the drive cable. Evidence of the 6 weld points found in the distal housing and drive cable. All the diameter measurements are within the specifications. It was observed that the catheter flushed normally. Impedance testing shows an electrical open at distal wave form. Full image characterization cannot be performed due to detachment. 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
Same case as: 2134265-2017-05583. It was reported that tip detachment occurred. An ultra ice¿ diagnostic catheter was selected for use. During the procedure, the physician used the first ultra ice¿, however, it was noticed that the tip of ultra ice¿ was detached after long use and the catheter stopped spinning. Another ultra ice¿ was used but the same issue occurred. The procedure was completed with using the third ultra ice¿ diagnostic catheter. No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Updated: ae or product problem from reported issue is both an adverse event and product problem to product problem. Updated: type of reportable event from serious injury to malfunction. Updated: describe event or problem. (b)(4).
 
Event Description
It was further reported that the tip detaches within the catheter housing. It doesn't actually detach itself into the patient. The catheter itself remains intact. There was/is an issue with the weld at the tip point.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that the tip detaches within the catheter housing. It doesn't actually detach itself into the patient. The catheter itself remains intact. There was/is an issue with the weld at the tip point.
 
Manufacturer Narrative
(b)(4). The device has not been returned 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
Same case as: 2134265-2017-05583. It was reported that tip detachment occurred. An ultra ice¿ diagnostic catheter was selected for use. During the procedure, the physician used the first ultra ice¿, however, it was noticed that the tip of ultra ice¿ was detached after long use and the catheter stopped spinning. Another ultra ice¿ was used but the same issue occurred. The procedure was completed with using the third ultra ice¿ diagnostic catheter. No patient complications were reported and the patient's status was stable.
 
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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 Key6614397
MDR Text Key108799541
Report Number2134265-2017-05584
Device Sequence Number1
Product Code DXK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/09/2019
Device Model NumberM00499120
Device Catalogue Number9912
Device Lot Number20268633
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/06/2017 Patient Sequence Number: 1
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