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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SMALL PERIPHERAL CUTTING BALLOON¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - GALWAY SMALL PERIPHERAL CUTTING BALLOON¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number M001BPM3515140F0
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 12/15/2016
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Event Description
It was reported that a shaft detachment occurred.The 90% stenosed target lesion was locate in the mildly tortuous and mildly calcified left femoral artery.A 3.50 mm/4.5 cm/140 cm small peripheral cutting balloon was selected for use.During preparation, it was noted that the balloon protector was difficult to remove from the balloon.Subsequently, the shaft part became detached.The procedure was completed with another of the device.No patient complications were reported and the patient's condition was good.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual examination of the balloon, blades, tip was performed and revealed no damage.The balloon protector was still attached to the balloon.Internal dimension of the balloon protector was taken and met specified range.A visual and tactile examination of the hypotube shaft was taken and revealed that no kinks were found along the shaft.Also, a visual and tactile examination of the polymer shaft extrusion found that the mid-shaft showed signs of stretching and had detached 4mm proximal from extruded polymer 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 considered handling damage as the event occurred without direct patient contact.(b)(4).
 
Event Description
It was reported that a shaft detachment occurred.The 90% stenosed target lesion was locate in the mildly tortuous and mildly calcified left femoral artery.A 3.50mm/ 4.5cm/140cm small peripheral cutting balloon¿ was selected for use.During preparation, it was noted that the balloon protector was difficult to remove from the balloon.Subsequently, the shaft part became detached.The procedure was completed with another of the device.No patient complications were reported and the patient's condition was good.
 
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Brand Name
SMALL PERIPHERAL CUTTING BALLOON¿
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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 Key6243475
MDR Text Key64602345
Report Number2134265-2016-12320
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
PMA/PMN Number
P950020
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 12/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/17/2018
Device Model NumberM001BPM3515140F0
Device Catalogue NumberBPM3515140F
Device Lot Number0018747505
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2016
Initial Date FDA Received01/11/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2016
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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