• 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 - MAPLE GROVE EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

  • 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 - MAPLE GROVE EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number UNK731
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 04/12/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. If there is any further relevant information, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr id: 2134265-2017-04247. It was reported that vessel dissection occurred. The target lesion was located in the calcified left anterior descending (lad) artery. An opticross¿ 6 imaging catheter was advanced for visualization but failed to cross. The device was removed and flushing was done to advanced the opticross again but then the physician could not get the telescope portion to come back to its original position, so another opticross imaging catheter was used instead. Subsequently, a 2. 25mm x 16mm synergy ii stent was advanced to treat the lesion. However, the device became stuck on either the recently deployed non-bsc stent or in the calcified lesion and the stent came off from the balloon inside the patient's body. The physician managed to crush the dislodged stent with a larger 3. 5mm x 20mm non-bsc stent in the lad to prevent embolization. After that, post-dilatation was done with 1. 5mm x 15mm emerge balloon catheter; moreover, a vessel dissection was noted after ballooning. The patient was then sent for bypass to treat the dissection. No further patient complications were noted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6533622
MDR Text Key74048725
Report Number2134265-2017-04569
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK731
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 Received04/12/2017
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: 05/01/2017 Patient Sequence Number: 1
Treatment
2.25MM X 16MM SYNERGY II STENT
-
-