• 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 NC QUANTUM APEX BALLOON CATHETER 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 NC QUANTUM APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number UNK651
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 06/16/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr id: 2134265-2017-06688. It was reported that vessel dissection occurred. Vascular access was obtained via the femoral artery. The 90% stenosed, 16mm in length, concentric, de novo target lesion was located in the mildly tortuous, mildly calcified, and 3. 50mm in diameter left anterior descending (lad) artery. After a non-bsc guidewire crossed the lesion, pre-dilation was performed using a non-bsc balloon catheter at 12 atmospheres. A 3. 50 x 16 synergy drug-eluting stent was advanced to treat the lesion and was deployed at 14 atmospheres for 25 seconds. Post-dilation was performed using a nc quantum apex balloon catheter. Fluoroscopy was then performed and dissection at proximal site of the stent was noted. A 3. 50x12mm synergy stent was then deployed to cover the dissection and the procedure was completed. No further patient complications were reported and the patient's status was stable and responding well to medicines.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNC QUANTUM APEX BALLOON CATHETER
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 Key6691961
MDR Text Key79229171
Report Number2134265-2017-06798
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K121667
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 06/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK651
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 Received06/19/2017
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: 07/06/2017 Patient Sequence Number: 1
-
-