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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 M001BP90720B0
Device Problems Cutter; Detachment Of Device Component
Event Date 07/06/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that blade detachment occurred. The target lesion was located in the subclavian artery. A 7. 00mm / 2. 0cm / 90cm peripheral cutting balloon was selected for use. During the procedure, the device was successfully dilated in the subclavian arteriovenous (av) fistula several times. As the device was withdrawn, it was noted to be stuck in the target lesion and the balloon and blades were detached from the shaft and was left in the vessel. The detached component were removed from the vessel using surgical technique. No further patient complications were reported and the patients status was stable.

 
Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis. The balloon was completely detached from the shaft and the balloon material was torn and a blade and pad was missing from the material; however, a visual and tactile examination identified no damage or weakness that may have caused the balloon to detach. The tip detached from the device along with the balloon. The detached tip was not returned for analysis. There is evidence of stretching at the site where the tip was molded onto the device. One of the blades/pads was missing from the returned balloon material. The remaining three blades were inspected and it was noted that one of them was lifted from the balloon material. A visual and tactile examination identified no kinking or damage along the shaft. No other issues from the rest of the device 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 blade detachment occurred. The target lesion was located in the subclavian artery. A 7. 00mm / 2. 0cm / 90cm peripheral cutting balloon¿ was selected for use. During the procedure, the device was successfully dilated in the subclavian arteriovenous (av) fistula several times. As the device was withdrawn, it was noted to be stuck in the target lesion and the balloon and blades were detached from the shaft and was left in the vessel. The detached component were removed from the vessel using surgical technique. No further patient complications were reported and the patients status was stable.

 
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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
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5843025
Report Number2134265-2016-06685
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/23/2016
Device MODEL NumberM001BP90720B0
Device Catalogue NumberBP907020B
Device LOT Number16917497
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/29/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/14/2014
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: 08/03/2016 Patient Sequence Number: 1
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