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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); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2023
Event Type  malfunction  
Event Description
It was reported that a shaft fracture occurred.A 2.00mm x 30mm emerge balloon catheter was selected for use.The emerge balloon catheter was withdrawn from the patient and a shaft fracture was observed.Another emerge balloon catheter was selected to complete the procedure.No patient harm resulted in relation to this event.
 
Event Description
It was reported that a shaft fracture occurred.A 2.00mm x 30mm emerge balloon catheter was selected for use.The emerge balloon catheter was withdrawn from the patient and a shaft fracture was observed.Another emerge balloon catheter was selected to complete the procedure.No patient harm resulted in relation to this event.It was further reported that the 2.00mm x 30mm emerge balloon catheter kinked during advancement to about 90 degrees.The device was being removed out of the guide catheter; the shaft broke in 2 pieces at the location of the kink.The lesion was 80% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.
 
Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the emerge balloon catheter.The hypotube, shaft, tip, and balloon were microscopically and visually examined.There was contrast in the inflation lumen.The balloon was tightly folded.Inspection of the device presented no shaft detachment to the shaft; however, it was revealed that there was a kink in the hypotube 50.5cm distal of the strain relief.Product analysis did not confirm the reported shaft detachment, as the shaft was not detached.However, the reported kink was confirmed, as the hypotube was kinked.
 
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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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16243263
MDR Text Key308124482
Report Number2124215-2023-02973
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeHU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7165
Device Catalogue Number7165
Device Lot Number0028612551
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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