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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 H7493918908220
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 04/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that shaft break occurred.A 2.25mm x 8mm emerge¿ balloon catheter was selected for use.However, after prepping the device and was attempted to back-load the balloon catheter on the wire, the hypotube shaft broke in half.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge balloon catheter device.The balloon was tightly folded.Microscopic and tactile inspection revealed numerous kinks in the hypotube of the device.The hypotube was fractured 59cm from the strain relief.The fracture faces were oval, indicating the area was kinked prior to fracturing.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
 
Event Description
It was reported that shaft break occurred.A 2.25mm x 8mm emerge¿ balloon catheter was selected for use.However, after prepping the device and was attempted to back-load the balloon catheter on the wire, the hypotube shaft broke in half.No patient complications were reported.
 
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Brand Name
EMERGE¿
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5647519
MDR Text Key45033245
Report Number2134265-2016-03804
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 Physician
Type of Report Initial,Followup
Report Date 04/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2018
Device Model NumberH7493918908220
Device Catalogue Number39189-0822
Device Lot Number0018777140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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