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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 M001PCB6020900
Device Problems Cutter; Detachment of Device or device Component
Event Type  Injury  
Manufacturer Narrative

(b)(4). Device evaluated by manufacturer: the device was not returned for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.   (b)(4).

 
Event Description

It was reported that a detach balloon blade occurred. The target lesion was located in the left pulmonary artery. A 6mm x 2cm peripheral cutting balloon® was selected for use. During procedure, the balloon was removed from the patient's body when it was noted that the one of the balloon blades came off and ended up in the left pulmonary artery. The detached blade was snared without causing any harm to the patient. The procedure was completed with this device. No further patient complications were noted and the patient's status was okay.

 
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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 Key6814738
Report Number2134265-2017-08368
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/26/2019
Device MODEL NumberM001PCB6020900
Device Catalogue NumberPCB602090
Device LOT Number20568528
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 Received08/03/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/19/2017
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: 08/23/2017 Patient Sequence Number: 1
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