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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 Problem Deflation Problem (1149)
Patient Problems Arrhythmia (1721); Myocardial Infarction (1969); Vascular Dissection (3160)
Event Date 07/31/2021
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that balloon deflation failure and subsequent patient complications occurred.Vascular access was obtained via the radial artery.The 90% tightly stenosed, 3x30mm, concentric, de novo target lesion was located in the mildly tortuous and non-calcified left anterior descending (lad) artery.A 2.50mm x 15mm emerge balloon catheter was advanced for pre-dilation.On the first inflation, the balloon was slowly inflating up to 12 atmospheres.However, after the second inflation, the balloon was not able to deflate even after using a different inflation/deflation device.The patient went into ventricular tachycardia and was in a critical situation.The patient also experienced st elevation myocardial infarction.A deep intubation of the catheter was performed and the device was removed together with the guide catheter and the wire.The angiography showed a dissection of the medium lad.When the procedure was completed, there were two stents implanted in the lad.No further patient complications were reported.
 
Event Description
It was reported that balloon deflation failure and subsequent patient complications occurred.Vascular access was obtained via the radial artery.The 90% tightly stenosed, 3x30mm, concentric, de novo target lesion was located in the mildly tortuous and non-calcified left anterior descending (lad) artery.A 2.50mm x 15mm emerge balloon catheter was advanced for pre-dilation.On the first inflation, the balloon was slowly inflating up to 12 atmospheres.However, after the second inflation, the balloon was not able to deflate even after using a different inflation/deflation device.The patient went into ventricular tachycardia and was in a critical situation.The patient also experienced st elevation myocardial infarction.A deep intubation of the catheter was performed and the device was removed together with the guide catheter and the wire.The angiography showed a dissection of the medium lad.When the procedure was completed, there were two stents implanted in the lad.No further patient complications were reported.It was further reported that the physician considered the balloon extraction contributed to the dissection.
 
Manufacturer Narrative
A2: age at time of event - 18 years or older.
 
Manufacturer Narrative
A2: age at time of event - 18 years or older.Returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There were numerous significant bends to the hypotube of the device.There was contrast in the inflation lumen and the balloon.There was blood in the guidewire lumen, and the balloon was loosely folded.At 45mm from the tip of the device, the guidewire lumen was stretched down for a length of 5mm.At 40mm from the tip, the guidewire lumen was kinked.The distal portion of the balloon was prolapsed.The tip of the device was prolapsed and damaged.The device was soaked for a period of time to break up the contrast, it was then prepped with an inflation device filled with water to inflate the device to the rated burst pressure.The balloon was able to be inflated, maintained pressure , and deflated with no issue or irregularity.
 
Event Description
It was reported that balloon deflation failure and subsequent patient complications occurred.Vascular access was obtained via the radial artery.The 90% tightly stenosed, 3x30mm, concentric, de novo target lesion was located in the mildly tortuous and non-calcified left anterior descending (lad) artery.A 2.50mm x 15mm emerge balloon catheter was advanced for pre-dilation.On the first inflation, the balloon was slowly inflating up to 12 atmospheres.However, after the second inflation, the balloon was not able to deflate even after using a different inflation/deflation device.The patient went into ventricular tachycardia and was in a critical situation.The patient also experienced st elevation myocardial infarction.A deep intubation of the catheter was performed and the device was removed together with the guide catheter and the wire.The angiography showed a dissection of the medium lad.When the procedure was completed, there were two stents implanted in the lad.No further patient complications were reported.It was further reported that the physician considered the balloon extraction contributed to the dissection.
 
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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 johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12310922
MDR Text Key266161993
Report Number2134265-2021-10145
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeMO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/25/2023
Device Model Number7163
Device Catalogue Number7163
Device Lot Number0027226619
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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