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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 H7493919308200
Device Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2018
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of an emerge balloon catheter. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. There are numerous hypotube kinks. The tip is damaged. Inspection of the remainder of the device presented no damage or irregularities. Functional testing was carried out by attaching an inflation device filled with water to the hub of the complaint device, and inflating the device to nominal pressure. While the emerge balloon was inflated, a measurement was taken. There was no evidence of any damage or irregularities contributing to the reported event. The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event. (b)(4).
 
Event Description
It was reported that balloon length was incorrect. The target lesion was located in the right coronary artery. A 2. 00mm x 8mm emerge balloon catheter was advanced for pre-dilation. However, when the balloon was inflated, it measured 15. 5mm instead of 8mm. The device was completely removed from the patient and the procedure was completed. No patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that balloon length was incorrect. The target lesion was located in the right coronary artery. A 2. 00mm x 8mm emerge balloon catheter was advanced for pre-dilation. However, when the balloon was inflated, it measured 15. 5mm instead of 8mm. The device was completely removed from the patient and the procedure was completed. No patient complications were reported and the patient's status was fine.
 
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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 Key7264398
MDR Text Key265806697
Report Number2134265-2018-00779
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBE
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 01/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/13/2020
Device Model NumberH7493919308200
Device Catalogue Number39193-0820
Device Lot Number21399344
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2017
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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