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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 M001BP50520B0
Device Problems Cutter/Blade (777); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/24/2017
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 lifted. The 90% target lesion was located in the mildly tortuous shunt vein. A 5. 00mm/2. 0cm/50cm peripheral cutting balloon was selected for use. During procedure when removing the balloon from the sheath, it was noticed that the blade became lifted but no separation was noted. No patient complications were reported.

 
Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis. A visual examination confirmed that the balloon had been subjected to positive pressure and saline solution was visible within the balloon. Blood was observed within the lumen of the device. An examination of the device identified that 14. 5mm of blade and pad were completely detached from the balloon, 5. 5mm of blade and pad remained attached to the balloon. In addition, the total size of the blade is 2cm and the detached 14. 5mm of the blade and pad were not returned for analysis. No issue was observed with the balloon, tip or markerbands of the device. A visual and tactile examination found multiple kinks along the shaft of the device. This type of damage is consistent with excessive force being applied to the delivery system during device use. 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 reported that the blade was lifted. The 90% target lesion was located in the mildly tortuous shunt vein. A 5. 00mm/2. 0cm/50cm peripheral cutting balloon® was selected for use. During procedure when removing the balloon from the sheath, it was noticed that the blade became lifted but no separation was noted. No patient complications were reported.

 
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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 Key6418167
MDR Text Key70425862
Report Number2134265-2017-02222
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 02/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/20/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/27/2018
Device MODEL NumberM001BP50520B0
Device Catalogue NumberBP505020B
Device LOT Number0019417697
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/06/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/14/2016
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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