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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - GALWAY SYNERGY BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number UNK425
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Obstruction/Occlusion (2422)
Event Date 12/12/2017
Event Type  Death  
Manufacturer Narrative
Device is a combination product. It is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
It was reported that the patient died. The 90% stenosed target lesion was located in the mid right coronary artery (rca). A 3. 50 x 20mm synergy drug eluting stent was placed and balloon inflation was performed in the distal rca. Slow flow was then observed and intra-aortic balloon pump (iabp) procedure was performed resulting in no flow, decrease of blood pressure, and ventricular tachycardia (vt). Bosmin administration was performed and even though blood pressure and heart rate temporarily increased, ventricular fibrillation (vf) occurred from vt, and cardiopulmonary resuscitation (cpr) was started. Return of spontaneous circulation (heartbeat) was observed several times but temporarily. In parallel, an external cardiac pacemaker was placed. An attempt was made to secure the blood vessel, but difficulties were encountered due to severe arteriosclerosis. Emergency thoracotomy was performed and while open chest cardiac massage was performed, blood transmission was inserted in the ascending aorta. Cardiopulmonary bypass was started but the heartbeat was not recovered and it was difficult to maintain circulation. Death of the patient was then confirmed.
 
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Brand NameSYNERGY BALLOON DILATATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key7290446
MDR Text Key100730571
Report Number2134265-2018-01165
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K993305
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 01/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK425
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/22/2018 Patient Sequence Number: 1
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