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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 M001BPM4015140F0
Device Problems Detachment Of Device Component (1104); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 11/08/2014
Event Type  malfunction  
Event Description
It was reported that a balloon detachment occurred.The 90% stenosed target lesion was located in the severely calcified shunt.A 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ monorail was used to treat the target lesion.During preparation, while removing the balloon protector, the balloon was detached from the shaft of the device.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was good.
 
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Manufacturer Narrative
Corrected from: "the balloon protector and the detached balloon were not returned" to "the balloon protector cap was returned positioned over the balloon." additional investigation results: the proximal blade sections were exposed which is indicative of the balloon protector being pulled distally.The returned balloon protector inner dimension was verified.(b)(4).
 
Event Description
It was reported that a balloon detachment occurred.The 90% stenosed target lesion was located in the severely calcified shunt.A 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ monorail was used to treat the target lesion.During preparation, while removing the balloon protector, the balloon was detached from the shaft of the device.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was good.
 
Manufacturer Narrative
(b)(4).Device evaluated by manufacturer: investigation completed.The device was returned for evaluation.However, the balloon protector and the detached balloon were not returned.Device analysis observed the inner lumen had detached at the distal tip/balloon bond and the outer lumen had detached at the proximal balloon bond which resulted in a complete detachment of the balloon from the delivery system.The distal tip/balloon bond length measured 3 mm the proximal balloon bond (matte finish) measured 1 mm in length.The markerbands remained on the distal section of the inner lumen.No damage was noted to the catheter shaft.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 balloon detachment occurred.The 90% stenosed target lesion was located in the severely calcified shunt.A 4.00mm/1.5cm/140cm small peripheral cutting balloon monorail was used to treat the target lesion.During preparation, while removing the balloon protector, the balloon was detached from the shaft of the device.The procedure was completed with another of the same 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
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4287202
MDR Text Key5296119
Report Number2134265-2014-07335
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 Foreign,Health Professional,Company Representative,Distributor,company represent
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/17/2016
Device Model NumberM001BPM4015140F0
Device Catalogue NumberBPM4015140F
Device Lot Number16618238
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received07/28/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2014
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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