Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 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 CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7163
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/31/2023
Event Type  malfunction  
Event Description
It was reported that device contamination occurred.Vascular access was obtained via the radial artery.The target lesion was located in the left anterior descending artery.A 3.00mm x 15mm fg emerge balloon catheter was selected for use.However, during unpacking it was noted that there was some kind of plastic on the balloon, stuck on the metal.There were no patient complications reported and the patient was stable.
 
Event Description
It was reported that device contamination occurred.Vascular access was obtained via the radial artery.The target lesion was located in the left anterior descending artery.A 3.00mm x 15mm fg emerge balloon catheter was selected for use.However, during unpacking it was noted that there was some kind of plastic on the balloon, stuck on the metal.There were no patient complications reported and the patient was stable.
 
Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the device underwent analysis.The device was visually and microscopically examined.There was contrast in the inflation lumen and the balloon.The balloon was tightly folded with blood present to the outside of the device.The midshaft bond area to the returned device was measured and found to not meet visual standards.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
pmt 741 persiaran cassia selat
bandarcassia, pulau pinan 14110
MY   14110
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17715308
MDR Text Key323010254
Report Number2124215-2023-46938
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7163
Device Catalogue Number7163
Device Lot Number0030097331
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received10/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-