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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 7134
Device Problem Deflation Problem (1149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event of (b)(6) 2019 is an estimated date based off the aware date as the exact event date was not reported.
 
Event Description
It was reported that the balloon had deflation issue.A 2.50mm x 20mm emerge balloon was selected for use.At the end of the procedure, it was noted that the attachments to the indeflator seemed to slip off and not stay attached.Subsequently, the emerge balloon was not deflating easily.The device was successfully removed from the patient's body.No patient complications were reported.
 
Event Description
It was reported that the balloon had deflation issue.A 2.50mm x 20mm emerge balloon was selected for use.At the end of the procedure, it was noted that the attachments to the indeflator seemed to slip off and not stay attached.Subsequently, the emerge balloon was not deflating easily.The device was successfully removed from the patient's body.No patient complications were reported.
 
Manufacturer Narrative
Date of event of (b)(6) 2019 is an estimated date based off the aware date as the exact event date was not reported.Device evaluated by mfr: the device was returned for evaluation.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.Microscopic inspection revealed tip damage.The device was soaked in a water bath for 18 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 able to inflate and deflate normally.Inspection of the remainder of the device presented no other damage or irregularities.
 
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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 Key9280621
MDR Text Key168071599
Report Number2134265-2019-13290
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729806325
UDI-Public08714729806325
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
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7134
Device Catalogue Number7134
Device Lot Number0024157592
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2019
Date Manufacturer Received12/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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