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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 7164
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/02/2021
Event Type  malfunction  
Event Description
It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed.A 2.50mm x 20mm emerge balloon catheter was selected for used.However, during procedure the shaft was broken.The procedure was completed with another of same device.Further information has been requested but has not been provided at this time.
 
Event Description
It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed.A 2.50mm x 20mm emerge balloon catheter was selected for used.However, during procedure the shaft was broken.The procedure was completed with another of same device.Further information has been requested but has not been provided at this time.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There was blood in the hub upon device return.At 62cm from the strain relief the hypotube was separated.The separated ends were ovaled in shape indicating the device was kinked prior to separation.At 55.6cm distal from the separation, the shaft was kinked.There was contrast and blood present in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded and had contrast present in the balloon.
 
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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 Key12617425
MDR Text Key276381835
Report Number2134265-2021-12776
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAS
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 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/20/2023
Device Model Number7164
Device Catalogue Number7164
Device Lot Number0026561977
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2020
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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