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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 H7493918915300
Device Problem Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of an emerge balloon catheter. The balloon was loosely folded with fluid in the balloon and inflation lumen. The inner lumen/shaft and markerbands were microscopically inspected. Inspection found no damage or irregularities. Both markerbands were crimped onto the inner lumen, at the balloon body/cone transition points. The device was sent to mass transfer-area coefficient (mtac) for energy dispersive spectroscopy (eds) spectra analysis, and the markerbands showed the presence of the elements pt (platinum) and ir (iridium). Inspection of the remainder of the device found no damage or irregularities. There was no evidence of any damage or irregularities contributing to the reported markerband difficulty. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause was unable to be determined. Bsc id: (b)(4).
 
Event Description
It was reported that the radiopaque markerbands were unable to be seen. A 3. 00mm x 15mm emerge¿ balloon catheter was advanced to dilate a coronary vessel. However, while inside the patient, the marker bands could not be seen. The procedure was completed with this device. No patient complications were reported and the patient was not harmed.
 
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 radiopaque markerbands were unable to be seen. A 3. 00 mm x 15 mm emerge¿ balloon catheter was advanced to dilate a coronary vessel. However, while inside the patient, the marker bands could not be seen. The procedure was completed with this device. No patient complications were reported and the patient was not harmed.
 
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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 Key6584597
MDR Text Key199821726
Report Number2134265-2017-05142
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113220
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 05/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Model NumberH7493918915300
Device Catalogue Number39189-1530
Device Lot Number20376950
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2017
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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