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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 M001PCB7020900
Device Problems Cutter/Blade (777); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2015
Event Type  Malfunction  
Event Description

It was reported that a cutting balloon blade was lifted. The target lesion was located in the common hepatic duct. A 7. 00mm/2. 0cm/90cm peripheral cutting balloon® was used for dilation. During removal of the balloon from an unspecified 8fr sheath, the "cutting balloon possibly peeled from the balloon". The sheath and the balloon were removed from the patient. The procedure was completed with a different device. There were no patient complications reported and the patient's condition was fine.

 
Event Description

It was reported that a cutting balloon blade was lifted. The target lesion was located in the common hepatic duct. A 7. 00mm/2. 0cm/90cm peripheral cutting balloon® was used for dilation. During removal of the balloon from an unspecified 8fr sheath, the "cutting balloon possibly peeled from the balloon. " the sheath and the balloon were removed from the patient. The procedure was completed with a different device. There were no patient complications reported and the patient's condition was fine.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for evaluation. A visual examination observed one blade and blade pad had lifted from the balloon's proximal body; however, 3 mm of the proximal section of the blade pad was still intact. Visual and microscopic analysis of the device also observed that there was no damage on the tip. A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure. An examination of the markerbands identified no issues. Moreover, a visual and tactile examination found no kinks along the entire shaft. 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).

 
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Brand Name2CM PERIPHERAL CUTTING BALLOON®
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4522866
MDR Text Key5495107
Report Number2134265-2015-01027
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/18/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/27/2016
Device MODEL NumberM001PCB7020900
Device Catalogue NumberPCB702090
Device LOT Number0017401954
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/29/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/11/2014
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: 02/18/2015 Patient Sequence Number: 1
Treatment
8FR SHEATH
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