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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 M001BP50520B0
Device Problems Cutter; Detachment of Device or device Component
Event Date 07/05/2018
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr: the device was returned for analysis. A visual and microscopic examination was performed on the returned device. The customer¿s introducer sheath was not returned for analysis. The balloon was returned partially inflated with inflation medium within the balloon material. A visual and microscopic examination was performed on the balloon material. No damage was noted with the balloon material. During analysis the investigator deflated the balloon material without any issues notes. A visual and microscopic examination noted that one of the blades and most of the pad were completely detached from the balloon material. The detached blade and pad were also returned for analysis. This blade damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device. All other blades were present and fully bonded to the balloon material. No issues were noted with the blades or pads that have contributed to the complaint incident. A visual and tactile examination found no kinks or damage along the shaft of the device. A visual and tactile examination identified no issues with the markerband or tip that could have contributed to the complaint incident. 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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

 
Event Description

It was reported that the blade was detached. The 5mm, 30mm target lesion was located in the cephalic vein. A 5. 00mm/ 2. 0cm/ 50cm peripheral cutting balloon¿ was selected for use. During procedure, it was noted that the blade was detached. The detached blade was found caught in the distal end of the sheath and was removed from the patient's body together with the sheath. The physician considered that the lesion was not so hard causing the blade to peel off. No further patient complications were reported and the patient's status post-procedure was good.

 
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Brand Name2CM PERIPHERAL CUTTING BALLOON¿
Type of DeviceCATHETER, 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 Key7784775
Report Number2134265-2018-07143
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 07/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001BP50520B0
Device Catalogue NumberBP505020B
Device LOT Number0021694436
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/23/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/02/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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