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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 M001PCB80201350
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Date 03/22/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: the device was not returned for evaluation. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu. (b)(4).
 
Event Description
It was reported that patient bleeding occurred. The target lesion was located in the subclavian vein. Vascular access was obtained through the left radial artery. An 8. 00mm/2. 0cm/135cm peripheral cutting balloon® was selected for use. During the procedure, the physician was successfully able to dilate the patient¿s blood vessel. An unspecified sheath was then placed and the balloon was attempted to be pulled; however, the puncture became enlarged and consequently, bleeding occurred on the left radial artery access site. The sheath was removed and replaced with a larger size and pressure was applied to the bleeding artery. Subsequently, the bleed was sutured and closed. The procedure was completed with a different device. There were no further patient complications reported and the 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 Key6461670
MDR Text Key71825988
Report Number2134265-2017-03321
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/10/2019
Device Model NumberM001PCB80201350
Device Catalogue NumberPCB8020135
Device Lot Number0020145456
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 Received03/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2017
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: 04/05/2017 Patient Sequence Number: 1
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