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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ENDOVIVE¿ ONE STEP BUTTON¿ TUBE, GASTRO-ENTEROSTOMY

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) ENDOVIVE¿ ONE STEP BUTTON¿ TUBE, GASTRO-ENTEROSTOMY Back to Search Results
Model Number M00568510
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. However, the complainant reported that the device was not expired. According to the complainant, the suspect device is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a one step button initial placement gastrostomy kit was used in the stomach during a gastrostomy procedure. According to the complainant, during the procedure, it was noticed that the surgical drape was stuck to the seal inside the sterile kit. Reportedly, there was no visible damage on the device packaging. The procedure was still completed with this device. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be "no injury. ".
 
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Brand NameENDOVIVE¿ ONE STEP BUTTON¿
Type of DeviceTUBE, GASTRO-ENTEROSTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key6341363
MDR Text Key67824140
Report Number3005099803-2017-00444
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
PMA/PMN Number
K910584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 01/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00568510
Device Catalogue Number6851
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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