• 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 Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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# 2134265-2016-06541. (b)(6) clinical study. It was reported that balloon positioning problems were encountered. In (b)(6) 2012, the patient presented due to stable angina and cardiac catheterization was performed. Target lesion #1 was a de novo lesion located in the proximal right coronary artery (rca) with 90% stenosis and was 12mm long with a reference vessel diameter of 3. 00mm. Target lesion #1 was treated with pre-dilatation and placement of a 4. 00x16mm promus element plus drug-eluting stent, with 0% residual stenosis. Target lesion #2 was a de novo lesion located in the mid rca with 70% stenosis and was 10. 00mm long with a reference vessel diameter of 4. 00mm. Target lesion #2 was treated with pre-dilatation and placement of a 4. 00x12mm promus element plus drug-eluting stent, with 0% residual stenosis. Target lesion #3 was a de novo lesion located in the right posterior descending artery (r-pda) with 80% stenosis and was 10. 00mm long with a reference vessel diameter of 3. 50mm. Target lesion #3 was treated with pre-dilatation and placement of a 3. 50x12mm promus element plus drug-eluting stent, with 0% residual stenosis. Post-deployment of the study stents, coronary artery spasm was noted which was treated with the administration of intracoronary nitroglycerin. The following day, the patient was discharged on aspirin and clopidogrel. In (b)(6) 2015, the patient presented with complaints of worsening shortness of breath and chest pressure which radiates to bilateral arms. Subsequently, the patient was diagnosed with coronary artery disease, was hospitalized, and coronary angiography was performed on the same day. The 70% isr located in the proximal rca was treated with dilatation using a 3. 5 x 12. 00mm emerge balloon catheter. However, repeated watermelon seeding was noted. Subsequently, cutting balloon angioplasty was performed with a 3. 5 x 10. 00mm balloon, resulting in less than 30% residual stenosis. The following day, the event was considered resolved and the patient was discharged on aspirin and clopidogrel.
 
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
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5826608
MDR Text Key50574385
Report Number2134265-2016-06561
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 06/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2016
Is this an Adverse Event Report? No
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 Received06/30/2016
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

-
-