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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS - PI CATHETER, ULTRASOUND, INTRAVASCULAR

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BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS - PI CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 1816-06
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2019
Event Type  Injury  
Event Description
It was reported that advancement difficulties were encountered resulting in stent migration requiring additional intervention. A 16 x 90 x 100 vici self expanding stent was selected for a left common iliac stenting procedure. The non-thrombotic section to be treated was 20-30 mm. During the procedure, the stent was implanted with no complications. The leading edge of the stent was placed in the proximal lciv and extended to proximal leiv. The physician then attempted to advance multiple catheters into the stent and was met with resistance at the proximal ostium of the stent. When the physician was attempting to advance the ultra ice catheter into the stent to visualize it, the vessel was so tortuous that the catheter pushed against the end of the stent and it dislodged from where it was originally implanted. The leading edge of the stent was now in the distal ivc extending into the lciv. A balloon was used to pull the stent down and an apposing stent was placed from the distal ivc into the right civ and the stent on the left was extended into the leiv. No further patient complications were reported.
 
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Brand NameULTRA ICE PLUS - PI
Type of DeviceCATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9105396
MDR Text Key161055532
Report Number2134265-2019-11532
Device Sequence Number1
Product Code DXK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1816-06
Device Catalogue Number1816-06
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 Received08/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/23/2019 Patient Sequence Number: 1
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