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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; Detachment of Device or device Component
Event Date 07/12/2018
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that blade detachment occurred. The 6mm in diameter and 4cm target lesion was located in the moderately tortuous and non calcified shunt anastomosis site at forearm. A 6. 00mm/ 2. 0cm/ 5cm peripheral cutting balloon¿ was selected for use. During the procedure, after performing dilation 6 times in the shunt stenosis part of the forearm using the cutting balloon, resistance was felt when pulling the cutting balloon into the sheath. Consequently, the cutting balloon was again inflated without pulling forcibly and rewrap was attempted. Then, the balloon was able to be pulled into the sheath without resistance. When the balloon was checked after removal, it was noted that one blade was missing. The blade that detached was confirmed by fluoroscopy and ct scan and it was found out that the blade remained in the vein near the elbow. Then, the physician attempted to retrieve it using snare and it was successfully retrieved. The physician thought that the proximal side of the blade became stuck on the sheath when retracting the cutting balloon into the sheath that resulted to the blade to peel off. The procedure was completed with this device. 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 Key7751793
Report Number2134265-2018-06949
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 07/12/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001BP50620B0
Device Catalogue NumberBP506020B
Device LOT Number0021965067
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/19/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/09/2018
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: 08/06/2018 Patient Sequence Number: 1
Treatment
GUIDEWIRE: FUGA/ BSJ
ULTRA HIGH FLOW SHEATH/ 6F/ MEDIKIT
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