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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 7212
Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Integrity Problem (2978)
Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Seizures (2063)
Event Date 02/15/2020
Event Type  Injury  
Event Description
It was reported that patient experienced cardiac arrest.The 100% stenosed target lesion was located in the left circumflex coronary artery (lcx).After pre-dilation was performed with a 2.5x12mm unspecified balloon catheter, a 3.5mm unspecified stent was then placed in the lcx.Then post-dilation was tried to perform using a 3.50mm x 12mm nc emerge balloon catheter.However, the atmospheric pressure of the balloon was not increasing to the correct procedural pressure and was only reading at 8, which is very low, then the pressure began to drop.As the balloon was retracted, the patient started to seizure and this quickly escalated into a hypotensive event from no coronary flow to the left side of the heart.Cardio-pulmonary resuscitation and chest compressions were administered, and a code cart was called.After a while, spontaneous return of circulation occurred within the heart and the blood pressure returned to normal.The procedure was completed with another of the same device.Post procedure, it was observed that there was a crack in the line, about an inch down from the balloon on the shaft of the wire.They were able to test it with air flow pressure and could positively see air escaping the tubing.
 
Event Description
It was reported that patient experienced cardiac arrest.The 100% stenosed target lesion was located in the left circumflex coronary artery (lcx).After pre-dilation was performed with a 2.5x12mm unspecified balloon catheter, a 3.5mm unspecified stent was then placed in the lcx.Then post-dilation was tried to perform using a 3.50mm x 12mm nc emerge balloon catheter.However, the atmospheric pressure of the balloon was not increasing to the correct procedural pressure and was only reading at 8, which is very low, then the pressure began to drop.As the balloon was retracted, the patient started to seizure and this quickly escalated into a hypotensive event from no coronary flow to the left side of the heart.Cardio-pulmonary resuscitation and chest compressions were administered, and a code cart was called.After a while, spontaneous return of circulation occurred within the heart and the blood pressure returned to normal.The procedure was completed with another of the same device.Post procedure, it was observed that there was a crack in the line, about an inch down from the balloon on the shaft of the wire.They were able to test it with air flow pressure and could positively see air escaping the tubing.
 
Manufacturer Narrative
Returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a hole in the inner and outer shaft 61mm from the tip.The device was functionally tested with a.014 inch guidewire.The hole in the inner shaft is consistent with an interaction with a guidewire.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported leak.
 
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Brand Name
NC EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9825329
MDR Text Key183262248
Report Number2134265-2020-02747
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729846413
UDI-Public08714729846413
Combination Product (y/n)N
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/19/2021
Device Model Number7212
Device Catalogue Number7212
Device Lot Number0024799517
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2020
Date Manufacturer Received03/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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