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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 M001BP50820B0
Device Problems Cutter; Detachment Of Device Component
Event Type  Injury  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event. (b)(4).

 
Event Description

It was reported that the blade became detached and caused patient bleeding. A 8. 00mm/2. 0cm/50cm peripheral cutting balloon¿ was selected for use during a fistulaplasty with an unspecified 7f sheath. During the procedure, the 2cm peripheral cutting balloon¿ was inflated at nominal pressure of 6atm; however it was noted that during removal, the balloon became stuck on the sheath. Furthermore, the balloon cut through the sheath and cause significant amount of bleeding. Consequently, the physician replaced the damaged sheath. When the balloon was removed outside the patient, it was noted that it had a shard of metal sticking out of it and had blood all over it. No further 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 Key7603715
Report Number2134265-2018-05225
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/24/2019
Device MODEL NumberM001BP50820B0
Device Catalogue NumberBP508020B
Device LOT Number0020199811
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/24/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/14/2018 Patient Sequence Number: 1
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