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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 M001BP90620B0
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/12/2017
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Event Description
It was reported that blade detachment occurred.The 75% stenosed target lesion was located in the mildly tortuous and moderately calcified common femoral artery.A 2cm peripheral cutting balloon¿ was selected for use.During withdrawal, when the device was pulled into the sheath, it was noted that the balloon blade became detached.The blade was retrieved together with the balloon from the sheath.The procedure was completed with this device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination of the 2cm pcb device identified that 8mm of one of the blades has become completely detached from the proximal end of the balloon material, leaving 20mm of pad and 12mm of blade still attached to the balloon material.The detached section off blade was also returned for analysis.The entire 2cm of blade was accounted for.This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device most likely due to the operational context of the procedure.All other blades were present and fully bonded to the balloon material.No issues were noted with the blades or pads that could have contributed to the complaint incident.The balloon was unfolded which indicates it has been subjected to positive pressure.A visual and microscopic examination identified no damage or any issues with the balloon material that could have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along the shaft of the device.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 blade detachment occurred.The 75% stenosed target lesion was located in the mildly tortuous and moderately calcified common femoral artery.A 2cm peripheral cutting balloon¿ was selected for use.During withdrawal, when the device was pulled into the sheath, it was noted that the balloon blade became detached.The blade was retrieved together with the balloon from the sheath.The procedure was completed with this device.No patient complications were reported.
 
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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 Key6754895
MDR Text Key81495190
Report Number2134265-2017-07648
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
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 07/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/27/2018
Device Model NumberM001BP90620B0
Device Catalogue NumberBP906020B
Device Lot Number0019417538
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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