• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION SYNERGY CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problems Device-Device Incompatibility (2919); Material Deformation (2976); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/15/2018
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that inadequate apposition and stent damage occurred. The 90% stenosed, 5. 00mm in diameter target lesion was located in a moderately tortuous coronary artery. A 4. 0x20mm synergy drug-eluting stent was deployed to treat the lesion. However, when intravascular ultrasound (ivus) was performed with an opticross imaging catheter, it was noted that the stent was completely floating in the vascular lumen. When the opticross hd was pulled out from the blood vessel, slight resistance was encountered. Fluoroscopy was performed and revealed that the opticross got caught by the stent that was deployed inside the coronary artery. The stent strut was damaged and partially shrunk. The opticross was removed from the patient's body as it was not stuck, but the deployed stent was severely deformed. A balloon catheter was then advanced to post-dilate and fix the damaged stent and the procedure was completed. No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNERGY
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7857154
MDR Text Key119639509
Report Number2134265-2018-60867
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
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 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received08/16/2018
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 Initial

Patient Treatment Data
Date Received: 09/07/2018 Patient Sequence Number: 1
-
-