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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493919320300
Device Problem Deflation Problem (1149)
Patient Problems Non specific EKG/ECG Changes (1817); Pain (1994)
Event Date 05/05/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr. :returned product consisted of the emerge balloon catheter. The shaft, hypotube, welds, tip and balloon were microscopically and visually examined. There was contrast in the inflation lumen and balloon. The balloon was loosely folded and deflated when received. There were numerous kinks throughout the hypotube of the device. There was moderate stretching of the outer/inner. Functional testing was performed by attaching an inflation device filled with water to hub of the device. When positive pressure was applied, the balloon inflated right away and the catheter maintained constant pressure and there was no indication of any leaks or other anomalies. After confirming that device maintained rated burst pressure (rbp), an attempt to deflate the device by applying negative pressure with the inflation device was made; however, the device did not deflate. Inspection of the remainder of the device, revealed no other damage or irregularities. No other issues were identified during the product analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).
 
Event Description
It was reported that balloon deflation failure occurred and the patient experienced pain. The target lesion was located in the proximal left anterior descending (lad) artery. A 3. 00mm x 20mm emerge¿ balloon catheter was advanced for dilatation. During inflation, the physician noted that the balloon took much longer to inflate than the normal and thought there was no contrast in it. After an unspecified time, the balloon inflated to 6 atmospheres. However, when deflation was attempted, the balloon would not deflate even after pulling negative pressure on the inflator. Subsequently, the inflation device was removed and the physician attempted to manually deflate the balloon with a syringe but was unsuccessful. The patient started complaining of increasing pain and electrocardiogram (ecg) changes were noted as the balloon was blocking the lad. The physician was able to pull the still inflated balloon from the proximal lad and out through the guide catheter. No damages were noted to the lad or left main vessels. The physician was then able to continue placing a stent and the procedure was completed. No further patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr. : the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4),.
 
Event Description
It was reported that balloon deflation failure occurred and the patient experienced pain. The target lesion was located in the proximal left anterior descending (lad) artery. A 3. 00mm x 20mm emerge¿ balloon catheter was advanced for dilatation. During inflation, the physician noted that the balloon took much longer to inflate than the normal and thought there was no contrast in it. After an unspecified time, the balloon inflated to 6 atmospheres. However, when deflation was attempted, the balloon would not deflate even after pulling negative pressure on the inflator. Subsequently, the inflation device was removed and the physician attempted to manually deflate the balloon with a syringe but was unsuccessful. The patient started complaining of increasing pain and electrocardiogram (ecg) changes were noted as the balloon was blocking the lad. The physician was able to pull the still inflated balloon from the proximal lad and out through the guide catheter. No damages were noted to the lad or left main vessels. The physician was then able to continue placing a stent and the procedure was completed. No further patient complications were reported and the patient's status was stable.
 
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Brand NameEMERGE¿
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6560501
MDR Text Key108187423
Report Number2134265-2017-05056
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K113220
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 05/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberH7493919320300
Device Catalogue Number39193-2030
Device Lot Number20294124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2017
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: 05/11/2017 Patient Sequence Number: 1
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