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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/Blade (777); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/08/2015
Event Type  Malfunction  
Event Description

It was reported that the blade was partially lifted. The stenosed target lesion was located in the arm. A 6. 00mm/2. 0cm/90cm peripheral cutting balloon® was selected for fistulagram. During procedure, after a single inflation, the physician took the balloon from the sheath. It was noted that a portion of the cutter was partially lifted and was hanging off the balloon. The procedure was completed with this device. No patient complications were reported and the patient's status was fine.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Device evaluated by manufacturer. The device was returned for analysis. A visual examination identified that 5 mm of one blade and blade pad had lifted from the balloon's proximal body. However, 3. 5 mm of the proximal section of the blade pad was still intact. The remaining blades were fully bonded to the balloon and no damage was noted to the other blades and to the tip. It was also noted that the balloon was not folded which subjected to positive pressure. Blood was identified within the balloon and inflation lumen which is evidence of a device leak. The device was attached to an encore inflation unit. Positive pressure was applied when a leak was noted. A further microscopic analysis noted a pinhole at 5 mm distal to the distal end of the proximal markerband. No further damage was noted to the catheter. 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 partially lifted. The stenosed target lesion was located in the arm. A 6. 00mm/2. 0cm/90cm peripheral cutting balloon® was selected for fistulogram. During procedure, after a single inflation, the physician took the balloon from the sheath. It was noted that a portion of the cutter was partially lifted and was hanging off the balloon. The procedure was completed with this device. No patient complications were reported and the patient's status was fine.

 
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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 Key4480568
MDR Text Key15966651
Report Number2134265-2015-00181
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 01/08/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/03/2015
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 NumberM001PCB6020900
Device Catalogue NumberPCB602090
Device LOT Number0017401319
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/15/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/10/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/25/2014
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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