FLEXIMA? APDL M001271380 27-138

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-01 for FLEXIMA? APDL M001271380 27-138 manufactured by Boston Scientific - Costa Rica (coyol).

Event Text Entries

[107080164] (b)(4). Device evaluated by manufacturer: the device was not returned for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[107080165] It was reported that drain was implanted in the chest when hub detached. The target lesion was located in the chest. A flexima? Apdl was selected for use. The drain was successfully placed in the patient's chest in the interventional radiology (ir) suite. Then patient was taken back to the room. At some point, when the nurse checked on the drain, it was noted that the white hub of the drain was separated from the catheter and hanging by the locking wire. Patient was then taken back to ir to place another drainage catheter back inside the patient. No patient complications reported and patient's status was fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2018-04166
MDR Report Key7478063
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-05-01
Date of Report2018-04-09
Date Mfgr Received2018-04-09
Device Manufacturer Date2017-09-21
Date Added to Maude2018-05-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactEMP. SONALI ARANGIL
Manufacturer StreetONE SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634941700
Manufacturer G1BOSTON SCIENTIFIC - COSTA RICA (COYOL)
Manufacturer Street2546 FIRST STREET PROPARK FREE ZONE
Manufacturer CityALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXIMA? APDL
Generic NameTUBE, DRAINAGE, SUPRAPUBIC
Product CodeFFA
Date Received2018-05-01
Model NumberM001271380
Catalog Number27-138
Lot Number21154791
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - COSTA RICA (COYOL)
Manufacturer Address2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-01

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