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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 M001BP50620B0
Device Problems Cutter; Material Deformation
Event Date 12/22/2017
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 year or older. (b)(4).

 
Event Description

It was reported that the blade was lifted. A 6. 00mm x 2cm x 50cm peripheral cutting balloon was selected for use. During the procedure, balloon was inflated using a non bsc introducer sheath. However, it was observed that the blade of the proximal side was lifted up when it was removed. No patient complications were reported.

 
Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis. An examination of the device identified that one of the blades was partially detached from the balloon material. A microscopic examination identified that approximately 5mm of one of the blade was lifted from the proximal end of the balloon material. This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device. The remaining 15mm of the blade and the entire pad was intact and fully bonded to the balloon material. All other blades were intact and fully bonded to the balloon material. No issues were noted with the blades or pads that could have contributed to the complaint incident. All 2cm of blade was accounted for. A visual examination of the balloon noted that the balloon was unfolded which indicates it had been subjected to positive pressure. A microscopic examination of the balloon material identified no issues that could have contributed to the complaint incident. No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident. A visual and tactile examination identified no issues or any damage along the length 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 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 lifted. A 6. 00mm x 2cm x 50cm peripheral cutting balloon was selected for use. During the procedure, balloon was inflated using a non bsc introducer sheath. However, it was observed that the blade of the proximal side was lifted up when it was removed. No patient complications were reported.

 
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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 Key7197439
Report Number2134265-2017-13327
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 12/22/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/10/2019
Device MODEL NumberM001BP50620B0
Device Catalogue NumberBP506020B
Device LOT Number21236214
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/28/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/10/2017
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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