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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; Detachment of Device or device Component
Event Date 10/10/2017
Event Type  Injury  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4).

 
Event Description

It was reported that a blade detachment occurred and remained inside the patient's body. The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified right forearm and cephalic shunt. A 2cm peripheral cutting balloon¿ was selected for use. During procedure, a non-bsc introducer sheath was inserted and a non-bsc guidewire crossed the lesion in order to advance a non-bsc angiographic catheter up to the artery side and performed angiography. Another non-bsc guidewire was then advanced inside the angiographic catheter and then the cutting balloon was delivered to the target area. The cutting balloon was inflated from the distal side at 10atm for 30 sec, pulled back to the middle part and inflated at 8atm for 30sec and was further pulled back as 3rd inflation was done at 6atm for 30sec. A non-bsc angiographic catheter was advanced again to perform angiography. When the cutting balloon was checked post dilation at outside patient's body, a missing blade was noted as only 3 blades were confirmed. The sheath, catheterization table and device tray were checked during and after procedure but the blade was still nowhere to be found. A ct scan was then performed but still the location of the missing blade was not confirmed. As an eliminating method, it was determined that the missing blade remained inside the patient's body. The patient had an extended hospital stay per request as there were swelling of the affected limb and fever occurred. No further patient complications reported.

 
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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 Key6990896
Report Number2134265-2017-10557
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 10/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/14/2018
Device MODEL NumberM001BP90620B0
Device Catalogue NumberBP906020B
Device LOT Number19843502
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/13/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/08/2016
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: 10/31/2017 Patient Sequence Number: 1
Treatment
ANGIOGRAPHIC CATH- MEDIKIT NISHIYA 4FR
GUIDEWIRE- KYOUSHANT 18 150CM
INFLATION DEVICE- EVEREST
INTRODUCER SHEATH- MEDIKIT ULTRA HIGH FLOW 6FR 3CM
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