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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 M001BP90620B0
Device Problems Cutter; Physical Resistance; Material Deformation; Catheter
Event Date 12/21/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that the blade was peeled off. The target lesion was located in the forearm shunt. A 6. 00mmx2. 0cmx90cm peripheral cutting balloon¿ was selected for use. During procedure, the balloon was inflated. When the balloon was pulled out, resistance with the sheath was felt but it was successfully removed. However, it was noticed that about half of one blade was found to be peeled off. No patient complications were reported and the patient's condition 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 Key7186098
Report Number2134265-2017-13223
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 12/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/08/2018
Device MODEL NumberM001BP90620B0
Device Catalogue NumberBP906020B
Device LOT Number20981265
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/09/2018
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 Manufactured08/25/2017
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: 01/12/2018 Patient Sequence Number: 1
Treatment
GUIDEWIRE: FUGA
INTRODUCER SHEATH: 7F SHEATH
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