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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - CORK OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS Back to Search Results
Model Number M001173010
Device Problem Material Rupture (1546)
Patient Problems Hemorrhage/Bleeding (1888); No Consequences Or Impact To Patient (2199)
Event Date 12/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Same case as mdr id: 2134265-2017-12581.It was reported that the balloons ruptured and the patient required surgery.The patient presented with bilateral artery occlusion and placenta previa.Two 6-6/2/80 occlusion balloon catheters were advanced into the left and right femoral artery for dilation.No resistance was noted upon inserting the balloon and no imaging was performed as the patient was pregnant.The balloons were inflated to 2 atmospheres and the pressure immediately dropped.The patient was then successfully operated for the delivery of the baby and the balloon catheters were also removed.Upon removal, it was noted that the balloons were split.After the balloons were removed, the patient had a big bleed which prompted an emergency hysterectomy and the patient was on "hdu." no further patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the unit returned has balloon damaged, as part of overall visual revision.The balloon is burst.The catheter of the device is kinked approximately at 14.5 cm from the balloon hub, close to the bifurcation.Functional testing cannot be performed based on the returned condition of the balloon.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 further reported that imaging to aid in placement of the occlusion balloons was performed with image intensifier.The balloons were being used to occlude the internal iliac arteries, to provide an a-vascular field for a high risk c-section.The balloons were inflated once before they ruptured.In the opinion of the physician the balloons were not related to the report of "big bleed." the balloons were successfully removed following the c-section.The patient was on a high dependency unit following the procedure.The patient and baby are healthy.
 
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Brand Name
OCCLUSION BALLOON CATHETER
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI 
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI  
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7158473
MDR Text Key96185107
Report Number2134265-2017-12582
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K062202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/29/2018
Device Model NumberM001173010
Device Catalogue Number17-301
Device Lot Number20700531
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2017
Initial Date FDA Received01/02/2018
Supplement Dates Manufacturer Received01/08/2018
Supplement Dates FDA Received02/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age44 YR
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