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 7135
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event - used the first day of the month of the bsc aware date.Event date not provided.
 
Event Description
It was reported that ro marker band misalignment occurred.A 2.50mm x 30mm emerge balloon catheter was advanced for treatment.However, during inflation at 18 atmospheres, it was noted that the markers are not accurate as emerge balloon edge extends well past marker.There were no patient complications nor injuries reported.No further information available.
 
Manufacturer Narrative
(b3) date of event: corrected to (b)(6) 2020.
 
Event Description
It was reported that ro marker band misalignment occurred.A 2.50mm x 30mm emerge balloon catheter was advanced for treatment.However, during inflation at 18 atmospheres, it was noted that the markers are not accurate as emerge balloon edge extends well past marker.There were no patient complications nor injuries reported.No further information available.It was further reported that the target lesion was 80% stenosed located in the non-tortuous and mildly calcified mid left anterior descending artery.Following pre-dilatation, a non-bsc stent was deployed and completed the procedure.There were no patient complications reported and the patient's status was good.
 
Event Description
It was reported that ro marker band misalignment occurred.A 2.50mm x 30mm emerge balloon catheter was advanced for treatment.However, during inflation at 18 atmospheres, it was noted that the markers are not accurate as emerge balloon edge extends well past marker.There were no patient complications nor injuries reported.No further information available.It was further reported that the target lesion was 80% stenosed located in the non-tortuous and mildly calcified mid left anterior descending artery.Following pre-dilatation, a non-bsc stent was deployed and completed the procedure.There were no patient complications reported and the patient's status was good.
 
Manufacturer Narrative
(b3) date of event: corrected from (b)(6) 2020 to (b)(6) 2020.Device evaluated by mfr: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.The device was soaked in a water bath for five days to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The device was unable to be inflated as there was a tear on the shaft 26.6cm from the tip.The marker bands were 30mm apart, the distal marker band was 2mm from the distal end of the balloon, and the proximal marker band was 2mm from the proximal end of the balloon.There were no indications of marker band damage, or that the marker bands had moved.Inspection of the remainder of the device presented no other damage or irregularities.
 
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
two scimed place
maple grove MN 55311
MDR Report Key9818957
MDR Text Key183103824
Report Number2134265-2020-02610
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729806417
UDI-Public08714729806417
Combination Product (y/n)N
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 05/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/08/2022
Device Model Number7135
Device Catalogue Number7135
Device Lot Number0024745352
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2020
Initial Date Manufacturer Received 02/19/2020
Initial Date FDA Received03/11/2020
Supplement Dates Manufacturer Received03/24/2020
04/23/2020
Supplement Dates FDA Received04/16/2020
05/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-