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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC
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BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC Back to Search Results
Model Number 30935
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code Complaint, Ill-Defined (2331)
Date of Event 12/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.
 
Event or Problem Description
It was reported that the patient experienced serious injury.The pigtail of the flexima apdl remained locked even in an unlocked position.Consequently, a serious injury occurred due to the difficulty in removing the pigtail drain.No further patient complications reported.
 
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Brand Name
FLEXIMA APDL
Common Device Name
TUBE, DRAINAGE, SUPRAPUBIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8209625
Report Number2134265-2018-64682
Device Sequence Number10846318
Product Code FFA
UDI-Device Identifier08714729323112
UDI-Public08714729323112
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K944290
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/02/2019
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 Date01/31/2021
Device Model Number30935
Device Catalogue Number30935
Device Lot Number0021689435
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/13/2018
Initial Report FDA Received Date01/02/2019
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 Other;
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