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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493925116220
Device Problems Shaft; Hole In Material
Event Date 04/11/2018
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. Age at time of event: 18 years or older. (b)(6). (b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed. (b)(4).

 
Event Description

It was reported that there was a hole in the catheter shaft. The target lesion was located in the first diagonal artery and circumflex artery. A 16x2. 25mm promus premier¿ stent was selected for use. However, prior entering the guide catheter, a hole was noticed 5cm from the "ball". This was distal from the original exit hole which prevents the device from being advanced further. The device was replaced and the procedure was completed another stent. No patient complications were reported.

 
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Brand NamePROMUS PREMIER¿
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
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 Key7518750
Report Number2134265-2018-04282
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/18/2019
Device MODEL NumberH7493925116220
Device Catalogue Number39251-1622
Device LOT Number0021171772
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/01/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/18/2017
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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