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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 Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 11/01/2020
Event Type  Injury  
Manufacturer Narrative
Date of event. The date of the event is unknown. Bsc became aware of the event on (b)(6) 2020. Therefore, a date of (b)(6) 2020 was entered to indicate that the event occurred on an unknown day in (b)(6) 2020.
 
Event Description
It was reported that a shaft break and pain occurred. A percutaneous coronary intervention (pci) was performed on a calcified target lesion. A 3. 50 x 15mm emerge balloon was advanced to the dilate the target lesion. While withdrawing the device, resistance was encountered, and the monorail part of the catheter broke. The broken monorail part (the distal area of the catheter) was removed with a trapper balloon and a guiding catheter. The patient was reported to have pain, but was fully okay after the catheter was removed. The procedure was completed with another of the same device and no further patient complications were reported in relation to this event.
 
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Brand NameEMERGE
Type of DeviceCATHETERS, 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 Key10831079
MDR Text Key215974820
Report Number2134265-2020-15744
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7163
Device Catalogue Number7163
Device Lot Number0024783829
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/12/2020 Patient Sequence Number: 1
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