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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿ CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC - GALWAY SYNERGY¿ CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493926224220
Device Problems Balloon; Hole In Material
Event Date 03/19/2017
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. (b)(4). Device evaluated by mfr: the device was not returned for 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 additional information received on 10-may-2017. It was reported that balloon leak occurred. The target lesion was located in the left anterior descending (lad) artery. A 2. 25 x 24 synergy¿ drug-eluting stent was advanced to treat the lesion. However, it was noted that the balloon would not inflate because of a leakage. However, it was further reported that during the first inflation at 18 atmospheres, a balloon pinhole was noted. The device was completely removed from the patient's body and the procedure was completed with a balloon catheter. No patient complications were reported and the patient's status was good.

 
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Brand NameSYNERGY¿
Type of DeviceCORONARY DRUG-ELUTING STENT
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 Key6582734
Report Number2134265-2017-05153
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/07/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/17/2018
Device MODEL NumberH7493926224220
Device Catalogue Number39262-2422
Device LOT Number20115171
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/30/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/17/2017
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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