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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 7133
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 09/08/2020
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.A 2.50mm x 15mm emerge balloon catheter was selected for use.However, during preparation, the shaft of the balloon delivery system broke.The procedure was completed with another of the same device.No patient complications were 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 were numerous kinks.There was a complete separation at 75.8cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.
 
Event Description
It was reported that shaft break occurred.A 2.50mm x 15mm emerge balloon catheter was selected for use.However, during preparation, the shaft of the balloon delivery system broke.The procedure was completed with another of the same device.No patient complications were reported.
 
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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 Key10626647
MDR Text Key209777989
Report Number2134265-2020-13184
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729806219
UDI-Public08714729806219
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,health
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/24/2023
Device Model Number7133
Device Catalogue Number7133
Device Lot Number0025771353
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2020
Date Manufacturer Received11/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age51 YR
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