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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number M001BP90720B0
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Intimal Dissection (1333)
Event Date 10/27/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the balloon blade was partially detached and a vessel dissection occurred.A 7.00mm/2cm peripheral cutting balloon¿ was selected to dilate a stenosed arteriovenous fistula.Immediately after the stenosis was dilated it was noted that one of the balloon blades was partially detached.A digital subtraction angiography (dsa) run demonstrated active contrast extravasation that was successfully treated with a covered stent.No further patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Although the blades did not detach from the balloon, it was noted that a section of the blade and pad was lifted on the balloon.One of the blades/pads was lifted on the balloon.Approximately 7mm of the proximal section of the blade and pad was lifted on the balloon.The remaining three blades were inspected and no issues were noted.No tears or holes were identified in the balloon.The balloon was not refolded.Attempts to inflate the balloon failed.The device was immersed in warm water (37 degrees celsius), however the balloon failed to inflate.The restriction experienced is consistent with the build-up of solidified contrast media in the balloon/inflation lumen.No issues were identified with the tip.A visual and tactile examination identified no damage along the entire length of the shaft.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that the balloon blade was partially detached and a vessel dissection occurred.A 7.00mm/2cm peripheral cutting balloon¿ was selected to dilate a stenosed arteriovenous fistula.Immediately after the stenosis was dilated it was noted that one of the balloon blades was partially detached.A digital subtraction angiography (dsa) run demonstrated active contrast extravasation that was successfully treated with a covered stent.No further patient complications were reported and the patient's status was stable.
 
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Brand Name
2CM PERIPHERAL CUTTING BALLOON¿
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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 Key6115999
MDR Text Key60414975
Report Number2134265-2016-10457
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/20/2018
Device Model NumberM001BP90720B0
Device Catalogue NumberBP907020B
Device Lot Number19283309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2016
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;
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