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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 Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2017
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 stated that the device was used prior to the expiration date.(b)(4).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 percutaneous endoscopic gastrostomy (peg) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, when the physician was attempting to pull the one step button tube into the stomach it was pulled into the abdominal wall and was placed in the wrong area.The physician removed this device and the procedure was completed with a different device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
A visual examination of the one step button pull delivery system device revealed that the suture had been properly placed under the sheath during assembly as evidenced by the suture impression running from the suture hole to the proximal end of the sheath.Additionally the sheath had been pulled outward as the user pulled the suture perpendicular to the delivery system.The sheath was still attached to the delivery system and it was torn.The button section looks in good conditions without evidence of defects.It was noted that the condition of the returned device could not be evaluated with respect to the procedural factors encountered during the procedure (¿difficulty placing/retracting¿).It appears the suture tore the sheath as intended but the user could have difficulty during the placement of the device; this can be due to user technique, patient anatomy or other procedural factors.Therefore the most probable root cause of this complaint is ¿operational context¿, since it is most likely that due to anatomical and/or procedural factors encountered during the procedure, performance was limited.
 
Event Description
It was reported to boston scientific corporation that a one step button initial placement gastrostomy kit was used during a percutaneous endoscopic gastrostomy (peg) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, when the physician was attempting to pull the one step button tube into the stomach it was pulled into the abdominal wall and was placed in the wrong area.The physician removed this device and the procedure was completed with a different device.There were no patient complications reported as a result of this event.
 
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Brand Name
ENDOVIVE¿ ONE STEP BUTTON¿
Type of Device
TUBE, 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 Key6652084
MDR Text Key77935598
Report Number3005099803-2017-01887
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 Physician
Type of Report Initial,Followup
Report Date 05/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00568520
Device Catalogue Number6852
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/21/2017
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
Patient Sequence Number1
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