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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2021
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The target lesion was located in the middle left anterior descending artery.A 2.50mm x 15mm emerge balloon catheter was advanced for pre-dilation.However, upon advancing the device just beyond the tuohy, the shaft was cracked.The device was pulled back by hand and the procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 65.8cm from the strain relief.The separated ends were ovaled in shape indicating the device was kinked prior to separation.There were numerous kinks to the hypotube and shaft.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.
 
Event Description
It was reported that shaft break occurred.The target lesion was located in the middle left anterior descending artery.A 2.50mm x 15mm emerge balloon catheter was advanced for pre-dilation.However, upon advancing the device just beyond the tuohy, the shaft was cracked.The device was pulled back by hand and the procedure was completed with another of the same device.There were no patient complications 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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12962971
MDR Text Key281989789
Report Number2134265-2021-15621
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729806219
UDI-Public08714729806219
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/28/2024
Device Model Number7133
Device Catalogue Number7133
Device Lot Number0027420680
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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