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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 M001BP35620B0
Device Problems Failure to Advance; Catheter
Event Date 07/10/2018
Event Type  Malfunction  
Manufacturer Narrative

Age at the time of event: 18 years or older (b)(4). Device evaluated by manufacturer: the device was returned for analysis. A visual examination of the balloon observed that the balloon was not folded which indicates that the balloon was 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 and positive pressure was applied when liquid was observed to be leaking from a balloon pinhole approximately 5mm proximal to the proximal end of the distal markerband. An examination of the balloon material identified no issues which contributed to the initial issue. A visual and microscopic examination of the device identified no issues with the tip, markerbands or blades of the device that could have potentially contributed to the complaint incident. All blades were present and fully bonded to the balloon material. A visual and tactile examination identified no damage or any issues along the length of the shaft. 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

Reportable based on device analysis completed on 01-aug-2018. It was reported that the catheter failed to cross the lesion. The 80% stenosed target lesion was located in a moderately tortuous and moderately calcified left iliac artery. A 6. 00mm / 2. 0cm / 135cm otw 2cm peripheral cutting balloon¿ was selected for use. During procedure, after the device was inserted in a non bsc sheath, an attempt to advance the device to the target lesion was made. However, the lesion was hard and the device had difficult to advance. Somehow, dilatation was able to perform after the device reached the common iliac artery; however, the device failed to advance further to the external iliac artery. The device was removed from the patient and the procedure was completed with another of the same device. No patient complications were reported and the patient's condition was good. However, device analysis revealed a balloon pinhole.

 
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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 Key7790702
Report Number2134265-2018-07355
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 08/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/16/2020
Device MODEL NumberM001BP35620B0
Device Catalogue NumberBP1356020B
Device LOT Number0021999602
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/13/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/17/2018
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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