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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493926715250
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/13/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4) - attachment: (b)(4).
 
Event Description
It was reported via medwatch (b)(4) that balloon detachment occurred. The target lesion was located in a non-tortuous, mildly calcified circumflex (cx)/obtuse marginal branch (om) bifurcation. A 2. 0 x 15 mm nc emerge balloon was inflated twice at 18 atmospheres. After the lesion was stented, the same 2. 0 x 15 nc emerge balloon was advanced but resistance was encountered while trying to cross the stent struts. The balloon was left partially in the om from the cx. A 5. 0 x 15 mm nc emerge balloon was advanced to the cx in an attempt to help the 2. 0 x 15 mm balloon move forward to dilate the stent struts from the cx. Resistance was encountered on both balloons but the physician did not consider the resistance to be more than usual. The 5. 0 balloon was removed and when an attempt was made to remove the 2. 5 balloon, the balloon separated inside the patient about 5 mm from where the clear, soft portion of the balloon and the back soft portion started. A wire was twisted around the balloon to get the detached portion into the guide catheter. Another balloon was then inflated at low pressure to pin the broken 2. 5 balloon into the guide so it could be removed. The procedure was completed. There were no patient complications and the patient¿s status is fine.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter in two pieces. The balloon was loosely folded with blood in the inflation lumen and balloon. The outer shaft, inner shaft, balloon and tip were microscopically examined. The shaft is completely separated 23. 8cm from the distal tip. The fractured/separated ends of the shaft were stretched and jagged which indicates the shaft separation was due to tensile forces. The tip is damaged. There are numerous hyptotube and shaft kinks. Inspection of the remainder of the device presented no other damage or irregularities. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
It was reported via medwatch # 2300530000-2018-8002 that balloon detachment occurred. The target lesion was located in a non-tortuous, mildly calcified circumflex (cx)/obtuse marginal branch (om) bifurcation. A 2. 0x15mm nc emerge balloon was inflated twice at 18 atmospheres. After the lesion was stented, the same 2. 0x15 nc emerge balloon was advanced but resistance was encountered while trying to cross the stent struts. The balloon was left partially in the om from the cx. A 5. 0x15mm nc emerge balloon was advanced to the cx in an attempt to help the 2. 0x15mm balloon move forward to dilate the stent struts from the cx. Resistance was encountered on both balloons but the physician did not consider the resistance to be more than usual. The 5. 0 balloon was removed and when an attempt was made to remove the 2. 5 balloon, the balloon separated inside the patient about 5mm from where the clear, soft portion of the balloon and the back soft portion started. A wire was twisted around the balloon to get the detached portion into the guide catheter. Another balloon was then inflated at low pressure to pin the broken 2. 5 balloon into the guide so it could be removed. The procedure was completed. There were no patient complications and the patient¿s status is fine.
 
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Brand NameNC EMERGE®
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 Key7332387
MDR Text Key102160841
Report Number2134265-2018-01656
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 02/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/10/2020
Device Model NumberH7493926715250
Device Catalogue Number39267-1525
Device Lot Number21589535
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2018
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: 03/12/2018 Patient Sequence Number: 1
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