ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT UNK518

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 2018-07-02 for ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT UNK518 manufactured by Boston Scientific - Marlborough.

Event Text Entries

[112925424] Patient's date of birth is unknown; however, it was reported that the patient was born in (b)(6). (b)(6). The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown. The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[112925425] It was reported to boston scientific corporation that an endovive initial placement kit was used during a percutaneous endoscopic gastrostomy procedure. Procedure date is unknown; however, it was reported that it was placed in (b)(6) 2016. According to the complainant, a new stoma site was created and a new peg tube was placed. It was noticed that there was a leakage from the old stoma site it had pus and smelled. It was suspected to be infection. Reportedly, the nurse was advised to have it tested however results are unknown. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2018-02143
MDR Report Key7655690
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-07-02
Date of Report2018-06-06
Date Mfgr Received2018-06-06
Date Added to Maude2018-07-02
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. NANCY CUTINO
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834000
Manufacturer G1BOSTON SCIENTIFIC - MARLBOROUGH
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal Code01752
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
Generic NameGASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
Product CodePIF
Date Received2018-07-02
Model NumberUNK518
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - MARLBOROUGH
Manufacturer Address100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-07-02

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