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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 M001PCB5020900
Device Problems Cutter; Detachment of Device or device Component
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: under 18 years old. (b)(4).

 
Event Description

It was reported that the blade was partially detached. The target lesion was located in the mildly tortuous and moderately calcified pulmonary vein. A 2cm peripheral cutting balloon® was selected for use. During the procedure, a non bsc sheath was used with the 2cm peripheral cutting balloon® and went over a thruway 0. 18 wire. When the balloon came out of the non bsc sheath, it was noted that the blade almost came off. The procedure was completed with this device. No patient complications were reported and the patient's status was fine.

 
Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis. A visual and microscopic examination of the device identified that 6mm of one of the blades and pads was partially detached from the proximal end of the balloon material. The remaining section of blade and pad were noted to be fully attached to the balloon material. All other blades were intact and fully bonded to the balloon surface. The balloon was unfolded which indicates it had been subjected to positive pressure. An examination of the balloon material identified no issues. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

 
Event Description

It was reported that the blade was partially detached. The target lesion was located in the mildly tortuous and moderately calcified pulmonary vein. A 2cm peripheral cutting balloon was selected for use. During the procedure, a non bsc sheath was used with the 2cm peripheral cutting balloon and went over a thruway 0. 18 wire. When the balloon came out of the non bsc sheath, it was noted that the blade almost came off. 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
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key7122174
Report Number2134265-2017-12432
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/30/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/29/2019
Device MODEL NumberM001PCB5020900
Device Catalogue NumberPCB502090
Device LOT Number21194390
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/13/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/29/2017
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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