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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 H74938046830750
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 09/14/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device was not returned for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per product specification.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
 
Event or Problem Description
It was reported that stent dislodgment occurred.During preparation of an 8.0x30x75cm express® ld iliac / biliary stent, it was noted that the stent came off.The device never entered the patient's body and the procedure was completed with another of the same device.No patient complications were reported.
 
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Brand Name
EXPRESS® LD ILIAC / BILIARY
Common Device Name
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
MDR Report Key6913295
Report Number2134265-2017-09826
Device Sequence Number483354
Product Code NIO
UDI-Device Identifier08714729579670
UDI-Public08714729579670
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
P090003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/15/2017
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
Operator of Device Health Professional
Device Expiration Date03/03/2019
Device Model NumberH74938046830750
Device Catalogue Number38046-83075
Device Lot Number0018992627
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/15/2017
Initial Report FDA Received Date10/04/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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