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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; Detachment Of Device Component
Event Date 03/14/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that blade detachment occurred. The 80% stenosed target lesion was located in the moderately tortuous non-calcified subclavian vein. A 6. 00mm/ 2. 0cm/ 90cm peripheral cutting balloon¿ was selected for use along with a 6fr sheath and 0. 018 guidewire. The device was prepped and introduced into the patient. The device was inflated at nominal pressure and some recoil was suspected during applying pressure process. Dilatation was performed five times in the same area at nominal pressure. A good dilatation of the lesion area was obtained. When withdrawing the balloon catheter from the patient's body, it was noted that one blade came off the balloon. No resistance was felt during removal. Consequently, the physician performed fluoroscopy and ct examination and confirmed no blade was left inside the patient's body. Furthermore, the physician performed flushing of the sheath to search for the blade; however, the blade was not found. Lastly, the blade was searched inside the tray after but still not found. There was no abnormality or symptoms observed from the patient. The procedure was completed with this device. No patient complications were reported and patient's status was stable.

 
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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 Key7407269
Report Number2134265-2018-02724
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 03/14/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001BP90620B0
Device Catalogue NumberBP906020B
Device LOT Number0021324397
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/05/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2017
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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