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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 M001BP90620B0
Device Problems Cutter/Blade; Material Deformation
Event Date 12/25/2015
Event Type  Injury  
Manufacturer Narrative

Age at time of event: (b)(6) or older.  (b)(4).

 
Event Description

It was reported that the patient felt pain and the blade was lifted. The lesion was located in the moderately tortuous and moderately calcified upper arm shunt. A 6. 00mm x 2. 0cm x 90cm peripheral cutting balloon¿ was selected for use. During the procedure, the balloon was inflated but the position of the balloon moved a little and the patient felt pain. It was also noted that the blade was lifted. The device was successfully removed. The procedure was not completed and no further patient complications were reported.

 
Manufacturer Narrative

(b)(4).

 
Event Description

It was further reported that slight bleeding was found. The target lesion was located near the axillary vein. It was punctured with the sheath(7fr), a guidewire and the pcb balloon were passed the lesion, subsequently a balloon was inflated.

 
Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis. A visual and microscopic examination identified that approximately 6mm of the proximal section of the blade was lifted and detached. The pads were intact. This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device. The remaining blades were fully bonded to the balloon and no damage was noted to the other blades. No issues were noted with its profile. No other issues were identified during the product analysis. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).

 
Event Description

It was further reported that slight bleeding was found. The target lesion was located near the axillary vein. It was punctured with the sheath (7fr), a guidewire and the pcb balloon were passed the lesion, subsequently a balloon was inflated.

 
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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 Key5382439
Report Number2134265-2016-00050
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/21/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001BP90620B0
Device Catalogue NumberBP906020B
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/15/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2016
Was Device Evaluated By Manufacturer? Yes
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: 01/21/2016 Patient Sequence Number: 1
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