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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CHARGER PTA BALLOON DILATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - GALWAY CHARGER PTA BALLOON DILATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number UNK721
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Obstruction/Occlusion (2422)
Event Date 03/18/2016
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr:: the device was not received for analysis. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu. (b)(4).
 
Event Description
(b)(6) study. It was reported that an immediate recoil in the vessel post angioplasty occurred. In (b)(6) 2016, clinical status assessment identified the patient¿s qualifying conditions as rutherford category 3. Seven days later, the index procedure was performed. The target lesion was located in the right leg mid superficial femoral artery (sfa) with 100% stenosis and was 100mm long with proximal reference vessel diameter of 5. 4mm and distal vessel diameter of 5. 9mm and was classified as tasc ii a lesion. The target lesion was treated initially by angioplasty using a 6. 00 x 100mm charger balloon catheter; however, post angioplasty, there was an area of recoil noted in the mid sfa. Subsequently, a 6. 0 x 100mm non-bsc study stent was deployed, followed by post dilatation with residual stenosis of 10% and the procedure was completed.
 
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Brand NameCHARGER PTA BALLOON DILATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6648626
MDR Text Key77821330
Report Number2134265-2017-05884
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112697
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 05/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK721
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 Received05/22/2017
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: 06/16/2017 Patient Sequence Number: 1
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