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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 7165
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2019
Event Type  malfunction  
Event Description
It was reported the balloon was difficult to remove.An intervention was being performed.The 2.50mm x 30mm emerge balloon was used and became stuck in the patient's artery.
 
Event Description
It was reported the balloon was difficult to remove.A percutaneous coronary intervention was being performed on a 70% stenosed, calcified and tortuous lesion in the left anterior descending coronary artery.The 2.50mm x 30mm emerge balloon was inflated two times to 14 atmospheres and deflated; however, the balloon became stuck in the patient's artery.The balloon was safely removed from the patient.The procedure was successfully completed with a different device without issue or patient injury.The patient is currently doing very well.
 
Event Description
It was reported the balloon was difficult to remove.A percutaneous coronary intervention was being performed on a 70% stenosed, calcified and tortuous lesion in the left anterior descending coronary artery.The 2.50mm x 30mm emerge balloon was inflated two times to 14 atmospheres and deflated; however, the balloon became stuck in the patient's artery.The balloon was safely removed from the patient.The procedure was successfully completed with a different device without issue or patient injury.The patient is currently doing very well.
 
Manufacturer Narrative
Returned product consisted of the majority of an emerge balloon catheter.The midshaft was stretched and separated, with the distal portion of the device not returned.The separated ends were jagged and stretched indicating that the device was separated due to tensile overload.Measurements of the device was unable to be taken due to the condition of the device.The reported difficulty removing and separation were confirmed.
 
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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 Key9280015
MDR Text Key168288866
Report Number2134265-2019-13384
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
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 01/13/2020
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 Expiration Date01/01/2022
Device Model Number7165
Device Catalogue Number7165
Device Lot Number0023750873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2019
Date Manufacturer Received01/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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