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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 7163
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/17/2020
Event Type  malfunction  
Event Description
It was reported that a balloon burst occurred.A 2.50mm x 15mm emerge balloon was advanced to the target lesion, and after inflation the balloon burst.The procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient condition after the procedure was good.
 
Event Description
It was reported that a balloon burst occurred.A 2.50mm x 15mm emerge balloon was advanced to the target lesion, and after inflation the balloon burst.The procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient condition after the procedure was good.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge balloon catheter.The balloon was loosely folded with blood in the balloon and the inflation lumen.The device was soaked in a warm water bath for 2 days.Analysis of the tip, balloon, inner/outer shaft, and hypotube included microscopic and visual inspection.Inspection revealed tip damage (flared), and a hole (scrape) in the bottom of the port/exit notch.Inspection of the rest of the device found no other damage or defect.The device was leak tested in the lab, and water was found to be leaking from the hole/scrape in the port weld.The reported rupture was 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 Key9875794
MDR Text Key184808501
Report Number2134265-2020-03467
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
Report Date 04/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/02/2022
Device Model Number7163
Device Catalogue Number7163
Device Lot Number0024713101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2020
Date Manufacturer Received03/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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