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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7213
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2020
Event Type  Injury  
Event Description
It was reported that shaft break occurred. The 85% stenosed target lesion was located in the averagely tortuous and severely calcified mid right coronary artery. After a staged rotablator, the lesion was dilated with an emerge balloon catheter without issues, but upon removal from the patient's body the shaft then snapped 1/3 from the hub inside the 8fr guide catheter. The wire was pulled back into the guide catheter and snared the broken shaft without removing the guide catheter. The lesion then dilated with a different balloon catheter. A 2. 50 x 32 synergy drug-eluting stent was advanced but failed to cross and so another balloon was used to pre-dilate the lesion. The 2. 50 x 32 stent was advanced for the second time but the shaft broke at the mid portion of the catheter while advancing into the guide. The stent was pulled out from the guide catheter without removing the device from it. The procedure was completed with a different device. No patient complications were reported and the patient remained stable all throughout the procedure.
 
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Brand NameNC EMERGE
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 Key9912491
MDR Text Key187710283
Report Number2134265-2020-03897
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2021
Device Model Number7213
Device Catalogue Number7213
Device Lot Number0024596638
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2019
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: 04/01/2020 Patient Sequence Number: 1
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