FLEXIMA? M001271860 27-186

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-12 for FLEXIMA? M001271860 27-186 manufactured by Boston Scientific - Costa Rica (coyol).

Event Text Entries

[110807335] (b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[110807336] It was reported that the catheter became fractured and a fragment remained inside patient's body. A flexima? Drainage catheter was selected for use during nephrostomy under fluoroscopy guidance. During the procedure, the device kinked in several segments of the microguide. Consequently, upon removal, the device became fractured with a fragment of the device left in the lower renal pelvis. The procedure was stopped and re-scheduled as there was no other device available. No further patient complications reported and the patient's condition was stable.
Patient Sequence No: 1, Text Type: D, B5


[120863858] Device evaluated by mfr: the guidewire component was returned for analysis and damage was observed as part of overall visual revision. The drainage catheter was not returned for analysis. The coil was found unraveled at the distal section. Additionally, the core wire was broken. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[120863859] It was reported that the catheter became fractured and a fragment remained inside patient's body. A flexima? Drainage catheter was selected for use during nephrostomy under fluoroscopy guidance. During the procedure, the device kinked in several segments of the microguide. Consequently, upon removal, the device became fractured with a fragment of the device left in the lower renal pelvis. The procedure was stopped and re-scheduled as there was no other device available. No further patient complications reported and the patient's condition was stable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2018-05342
MDR Report Key7593227
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-06-12
Date of Report2018-05-25
Date of Event2018-05-20
Date Mfgr Received2018-08-31
Device Manufacturer Date2016-12-16
Date Added to Maude2018-06-12
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?
Generic NameTUBE, DRAINAGE, SUPRAPUBIC
Product CodeFFA
Date Received2018-06-12
Returned To Mfg2018-06-15
Model NumberM001271860
Catalog Number27-186
Lot Number20058153
Device Expiration Date2019-12-09
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - COSTA RICA (COYOL)
Manufacturer Address2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-06-12

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