ULTRA ICE PLUS? M00499120 9912

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-06 for ULTRA ICE PLUS? M00499120 9912 manufactured by Boston Scientific - Costa Rica (coyol).

Event Text Entries

[76745524] (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).
Patient Sequence No: 1, Text Type: N, H10


[76745525] 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.
Patient Sequence No: 1, Text Type: D, B5


[108799541] 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).
Patient Sequence No: 1, Text Type: N, H10


[108799542] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2017-05584
MDR Report Key6614397
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-06-06
Date of Report2017-05-17
Date of Event2017-05-17
Date Mfgr Received2017-09-27
Device Manufacturer Date2017-02-13
Date Added to Maude2017-06-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactEMP. SONALI ARANGIL
Manufacturer StreetONE SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634941700
Manufacturer G1BOSTON SCIENTIFIC - COSTA RICA (COYOL)
Manufacturer Street2546 FIRST STREET PROPARK FREE ZONE
Manufacturer CityALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameULTRA ICE PLUS?
Generic NameCATHETER, ULTRASOUND, INTRACARDIAC
Product CodeDXK
Date Received2017-06-06
Returned To Mfg2017-06-09
Model NumberM00499120
Catalog Number9912
Lot Number20268633
Device Expiration Date2019-02-09
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - COSTA RICA (COYOL)
Manufacturer Address2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-06-06

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