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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 Problems Stent; Activation, Positioning or Separation Problem
Event Date 10/07/2016
Event Type  Injury  
Manufacturer Narrative

Age at time of event: 18 years or older. Device is a combination product. (b)(4). Device evaluated by mfr: the complaint device was not returned for 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 reported that stent inadequate apposition occurred. The 100% stenosed target lesion was located in the severely tortuous distal left anterior descending (lad) artery. After a synergy drug-eluting stent was deployed to the lesion, intravascular ultrasound was performed and revealed that the stent was not properly apposed. Post dilatation was attempted with a 2. 50mm x 12mm emerge balloon catheter but failed to cross the malapposed stent. The physician decided not to continue with the emerge balloon catheter to avoid risks of stent deformation. The procedure was completed with a non-bsc balloon catheter. No patient complications were reported and the patient status was good.

 
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that stent inadequate apposition occurred. The 100% stenosed target lesion was located in the severely tortuous distal left anterior descending (lad) artery. After a synergy¿ drug-eluting stent was deployed to the lesion, intravascular ultrasound was performed and revealed that the stent was not properly apposed. Post dilatation was attempted with a 2. 50mm x 12mm emerge¿ balloon catheter but failed to cross the malapposed stent. The physician decided not to continue with the emerge¿ balloon catheter to avoid risks of stent deformation. The procedure was completed with a non-bsc balloon catheter. No patient complications were reported and the patient status was good.

 
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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 Key6067733
Report Number2134265-2016-09669
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/07/2016
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received10/31/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK425
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2017
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 Initial

Patient TREATMENT DATA
Date Received: 10/31/2016 Patient Sequence Number: 1
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