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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 M00568520
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2016
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18. The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. However, the complainant stated that the device was used prior to the expiration date. Reported event of tube migration. The device has been received for analysis. Upon 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.
 
Event Description
It was reported to boston scientific corporation that a one step button initial placement gastrostomy kit was used during a gastrostomy procedure. The procedure date is unknown. According to the complainant, post procedure, the nurse administered enteral nutrients to the patient. After 20 minutes, when the nurse checked the progress of the nutrient administration, it was noticed that the peg tube migrated into the stomach. The tube was removed endoscopically. The procedure was completed with a new one step button initial placement gastrostomy kit. Reportedly, the nutritional supplement might have been administered without gripping the peg tube.  there were no patient complications reported as a result of this event.
 
Manufacturer Narrative
A visual examination of the device found no issues and residue was present on the device indicating use/ handling. The button components were properly molded and assembled. The silicone material was pliable to touch and rebounded properly when compressed. The complaint device could not be functionally evaluated considering the procedural factor that it happened during the administering of the nutritional supplement. The complaint is due to a known physiological effect of the procedure noted within the directions for use. Based on all gathered information, the most probable root cause is "anticipated procedural complication. ".
 
Event Description
It was reported to boston scientific corporation that a one step button initial placement gastrostomy kit was used during a gastrostomy procedure. The procedure date is unknown. According to the complainant, post procedure, the nurse administered enteral nutrients to the patient. After 20 minutes, when the nurse checked the progress of the nutrient administration, it was noticed that the peg tube migrated into the stomach. The tube was removed endoscopically. The procedure was completed with a new one step button initial placement gastrostomy kit. Reportedly, the nutritional supplement might have been administered without gripping the peg tube. There were no patient complications reported as a result of this event.
 
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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 Key6248017
MDR Text Key64723414
Report Number3005099803-2016-04150
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00568520
Device Catalogue Number6852
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2017
Was Device Evaluated by Manufacturer? Yes
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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