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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/Blade (777); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/19/2017
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 peeling off. The target lesion was located in a shunt artery. A 6. 00 mm/2. 0 cm/50 cm peripheral cutting balloon¿ was selected for use. During the procedure, resistance was encountered during withdrawal and it was noted that the proximal part of the blade was peeling off. The procedure was completed with the same device. No patient complications were reported.

 
Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis. An examination of the device identified that 18mm of blade and pad lifted on the proximal end of balloon. 2mm of the blade was still attached to the distal end of the balloon. This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device most likely due to the operational context of the procedure. The device was returned with the balloon inflated. The investigator attached the returned unit to an encore inflation device and applied negative pressure. The balloon deflated in 3 seconds without issue using timer. A visual and tactile examination identified no kinks or damage along the shaft of the device. No other issues were identified during the product 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 further reported that the balloon was deflated during removal from the patient. Furthermore, the device was inflated again outside the patient's body to determine the condition of the balloon blades.

 
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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 Key6309042
MDR Text Key66734971
Report Number2134265-2017-00726
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
PMA/PMN NumberK070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/07/2017
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 NumberM001BP50620B0
Device Catalogue NumberBP506020B
Device LOT Number19566846
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/26/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/09/2016
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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