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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION PERCUFLEX; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 1094-05
Medical Device Problem Codes Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 07/29/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that there were removal difficulties.A percuflex ureteral stent was selected for use.During the procedure, when the string was cut and the physician pulled the catheter back, the device buckled up in the "neck".The procedure was cancelled.The patient would need to undergo surgery to remove the device from the body.
 
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Brand Name
PERCUFLEX
Common Device Name
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8916683
Report Number2134265-2019-10072
Device Sequence Number1828833
Product Code FAD
UDI-Device Identifier08714729048671
UDI-Public08714729048671
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K924608
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/06/2020
Device Model Number1094-05
Device Catalogue Number1094-05
Device Lot Number0021354772
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/29/2019
Initial Report FDA Received Date08/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age73 YR
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