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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC
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BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC Back to Search Results
Model Number 20226
Device Problems Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 10/04/2019
Event Type  malfunction  
Event Description
It was reported that device sterility was compromised.It was observed that an express ld iliac / biliary stent product box and device package was received damaged and the product pouch was compromised.The express stent was not used for a procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual and microscopic examination was performed on the returned packaging and device.The outer box carton was noted to be fully sealed and the blue tear tab was intact.A visual examination noted that the packaging was creased down the mid-section of the outer box carton.No issues were noted with the packaging that could have contributed to the damage identified.This damage is consistent with excessive force being applied to the packaging.The inner packaging was identified to be fully sealed.A visual examination identified no damage to the inner packaging.The outer and inner packaging were opened to allow for examination of the device.A visual and microscopic examination identified that the plastic protective tubing and express ld device were undamaged.No issues were noted with the device that could have contributed to the damage identified.No other issues were identified during analysis.
 
Event Description
It was reported that device sterility was compromised.It was observed that an express ld iliac / biliary stent product box and device package was received damaged and the product pouch was compromised.The express stent was not used for a procedure.
 
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Brand Name
EXPRESS LD ILIAC / BILIARY
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9244391
MDR Text Key164693060
Report Number2134265-2019-13033
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729392316
UDI-Public08714729392316
Combination Product (y/n)N
PMA/PMN Number
K133110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0024303683
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Date Manufacturer Received11/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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