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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY EXPRESS® LD ILIAC / BILIARY; STENT, ILIAC
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BOSTON SCIENTIFIC - GALWAY EXPRESS® LD ILIAC / BILIARY; STENT, ILIAC Back to Search Results
Model Number H74938046860750
Device Problem Inflation Problem (1310)
Patient Problem No Patient Involvement (2645)
Event Date 04/06/2015
Event Type  malfunction  
Event Description
It was reported that balloon profile problem occurred.The target lesion was located in the common iliac artery.An 8.0x60x75cm express® ld iliac / biliary stent was selected for use to treat the lesion.During preparation, the technician removed the device from the box.The technician was somewhat unsure if she had flushed the correct port as she noticed that the ends of the balloon looked a little bit larger than normal.The technician was sure that she had flushed the straight wire port but opted to use another express® ld iliac / biliary stent to complete the procedure.No patient complications were reported.
 
Manufacturer Narrative
(b)(6).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).
 
Manufacturer Narrative
Device evaluated by manufacturer: an examination of the returned device identified no anomalies which could potentially have contributed to the complaint incident.A visual and tactile examination of the entire device identified no kinks or damage along the shaft.The balloon was tightly folded and the stent was tightly crimped onto the balloon.The balloon did not appear to have been subjected to any positive pressure.An examination of the proximal and distal cone puffs identified no anomalies with their profiles.The balloon did not appear to have been subjected to any positive pressures.The stent was tightly crimped onto the balloon.No issues existed with the stent profile.The outer diameter of the crimped stent was measured and was within specification.An examination of the tip section of the device identified to issues with its profile.A 0.035inch size guidewire was inserted through the tip and wire lumen with no resistance noted.As part of the device analysis, the device was passed through a recommended size 7 fr sheath with no resistance noted.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 balloon profile problem occurred.The target lesion was located in the common iliac artery.An 8.0x60x75cm express® ld iliac / biliary stent was selected for use to treat the lesion.During preparation, the technician removed the device from the box.The technician was somewhat unsure if she had flushed the correct port as she noticed that the ends of the balloon looked a little bit larger than normal.The technician was sure that she had flushed the straight wire port but opted to use another express® ld iliac / biliary stent to complete the procedure.No patient complications were reported.
 
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Brand Name
EXPRESS® LD ILIAC / BILIARY
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4740924
MDR Text Key5828400
Report Number2134265-2015-02556
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P090003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/08/2018
Device Model NumberH74938046860750
Device Catalogue Number38046-86075
Device Lot Number0017588208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/24/2015
Initial Date FDA Received04/30/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/21/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age57 YR
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