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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 H7493919312250
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2016
Event Type  malfunction  
Manufacturer Narrative
(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 the balloon markers were misaligned. The patient presented with inferior st elevation myocardial infarction (stemi). A 2. 50mm x 12mm emerge¿ balloon catheter was selected to dilate the lesion. While the device was being placed, it was noticed that the balloon dilatation markers were incorrectly positioned. The procedure was completed with a different device. No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge balloon catheter device. The balloon was loosely folded and there was contrast in the balloon and inflation lumen. The balloon, markerbands, shaft and hypotube were microscopically and tactile inspected. Inspection revealed numerous kinks in the hypotube and a kink on the proximal end of the port/exit notch. Inspection of the markerbands revealed that they were placed 7mm and 13mm (respectively), and the proximal markerband appears slightly loose on the inner shaft (wire lumen). Inspection of the remainder of the device revealed no other damage or irregularities. Device analysis determined the condition of the returned device was consistent with the reported information. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The root cause has been determined to be manufacturing related. (b)(4).
 
Event Description
It was reported that the balloon markers were misaligned. The patient presented with inferior st elevation myocardial infarction (stemi). A 2. 50mm x 12mm emerge¿ balloon catheter was selected to dilate the lesion. While the device was being placed, it was noticed that the balloon dilatation markers were incorrectly positioned. The procedure was completed with a different device. No patient complications were reported.
 
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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 Key6186723
MDR Text Key62791345
Report Number2134265-2016-11942
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 12/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Model NumberH7493919312250
Device Catalogue Number39193-1225
Device Lot Number19106071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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