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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 7313
Device Problems Deflation Problem (1149); Leak/Splash (1354); Material Integrity Problem (2978)
Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Cardiac Tamponade (2226); Blood Loss (2597)
Event Date 12/14/2018
Event Type  Injury  
Event Description
It was reported that shaft rupture and balloon deflation failure occurred and that the patient experienced vessel rupture, heart tamponade and hypotension. The 90% stenosed, diffuse target lesion was located in a moderately tortuous and moderately calcified left anterior descending artery (lad) an intravascular ultrasound (ivus) catheter was advanced but was unable to cross the lesion. Dilation was performed using a 2mm non bsc balloon and the ivus was able to cross. The proximal to mid lad was dilated again using a 2. 50mm x 15mm nc emerge balloon catheter and a 2. 5mmx34mm non-bsc stent was implanted in the proximal to mid lad. The proximal lad was not sufficient and an attempt was made to place an 8mm stent in the insufficient part. Ivus was checked, but the first stent proximal was noted to be floating and dilation of the proximal stent was performed again with the same nc emerge balloon. On the third attempt, at 8 atmospheres, a false lumen formed between the middle and outer membrane near the opposite side of the left circumflex (lcx) artery, near the distal shaft of the balloon, and a large contrast media leak was noted. An attempt was made to deflate the balloon but pressure could not applied and the balloon could not be deflated. A rupture of the shaft lumen was suspected near the leakage. The false lumen of the vessel ruptured into the epicardium and heart tamponade occurred. Heart drainage was inserted surgically, and cardiac massage was continued for about an hour with cardiac support was inserted from the femoral artery. The ruptured anatomy was suppressed for 30 minutes, then another 30 minutes, and then 60 minutes using a non bsc device but the issue was not resolved. The ruptured part became bigger so a graft was placed across the lcx. While protecting the lcx, dilation was attempted so that the artery would not become completely flattened, but since bleeding could not be stopped, dilation and placement were performed completely blocking the lcx. The amount of bleeding to drainage was 650 cc. One day post procedure, blood pressure decreased greatly creating a dangerous situation. However, there was a gradual response on the pupil and such currently, and the level of consciousness was also improving somewhat.
 
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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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8246940
MDR Text Key133040985
Report Number2134265-2018-65091
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/12/2020
Device Model Number7313
Device Catalogue Number7313
Device Lot Number0021850698
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2018
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: 01/15/2019 Patient Sequence Number: 1
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