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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 20188
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Patient Involvement (2645)
Event Date 08/15/2019
Event Type  malfunction  
Event Description
It was reported that stent dislodgement occurred.During preparation of a 6.0mmx14mmx90cm express sd renal/biliary stent, the physician removed the plastic covering that was on top of the stent and at the same time the stent came with it.The device was replaced with another of the same device to complete the procedure.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the product was not received for analysis.However, there was a photo of the complaint device and detached stent.The photo was visually reviewed, and it showed that the stent was detached from the balloon.The balloon appeared to still be folded with stent impressions with a lot of bright red blood present at both ends of the balloon cones which appeared to be under the balloon folds.The stent impressions indicate that the stent was crimped on the stent prior to being placed in to the stent protector.As the stent protector was able to be placed on the crimped stent during manufacturing, this indicates that the device was manufactured correctly.With the amount of blood in the balloon cones and the appearance of the device in the photo, it looks like the device came into contact with blood and was not just prepped on the back table.Analysis was concluded based on the received photo of the complaint device.
 
Event Description
It was reported that stent dislodgement occurred.During preparation of a 6.0mmx14mmx90cm express sd renal/biliary stent, the physician removed the plastic covering that was on top of the stent and at the same time the stent came with it.The device was replaced with another of the same device to complete the procedure.No patient complications were reported.
 
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Brand Name
EXPRESS SD RENAL/BILIARY
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8943973
MDR Text Key155961249
Report Number2134265-2019-10297
Device Sequence Number1
Product Code NIN
UDI-Device Identifier08714729484837
UDI-Public08714729484837
Combination Product (y/n)N
PMA/PMN Number
K152607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/15/2020
Device Model Number20188
Device Catalogue Number20188
Device Lot Number0020649698
Was Device Available for Evaluation? No
Date Manufacturer Received09/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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