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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7172
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2020
Event Type  malfunction  
Event Description
It was reported that a foreign material was found at the tip of the device.A 1.20mm x 15mm emerge balloon catheter was opened and upon inspection the physician noticed a red foreign addition to the tip of the balloon.The balloon was replaced with another of the same device and there were no patient complications reported.
 
Event Description
It was reported that a foreign material was found at the tip of the device.A 1.20mm x 15mm emerge balloon catheter was opened and upon inspection the physician noticed a red foreign addition to the tip of the balloon.The balloon was replaced with another of the same device and there were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the guidewire lumen.The balloon was tightly folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported foreign material.
 
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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 Key11003497
MDR Text Key221293882
Report Number2134265-2020-17634
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K083094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/10/2021
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 Date02/27/2022
Device Model Number7172
Device Catalogue Number7172
Device Lot Number0025280809
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Initial Date Manufacturer Received 12/04/2020
Initial Date FDA Received12/14/2020
Supplement Dates Manufacturer Received02/19/2021
Supplement Dates FDA Received03/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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