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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ENDOVIVE¿ SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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BOSTON SCIENTIFIC - COSTA RICA (COYOL) ENDOVIVE¿ SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number M00566521
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2018
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.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 an endovive safety peg kit pull method was used during a gastrostomy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the tube was slightly pulled to check if it was properly and snugly placed, the peg tube detached.The procedure was completed with a new endovive safety peg kit pull method.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 with no injury.
 
Manufacturer Narrative
A visual examination of the returned device revealed that the feeding tube was broken approximately at 2cm from the dome.It was noted that the condition of the returned unit was consistent with the reported event of feeding tube detached/separated.It is most likely that the cause of the separation was that excessive force was applied during placement, while pulling the tube through the incision.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Based on the information available and the analysis performed, the most probable cause for the complaint will be documented as "operational context", probably due to anatomical/procedural factors encountered during the procedure, performance was limited.
 
Event Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during a gastrostomy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the tube was slightly pulled to check if it was properly and snugly placed, the peg tube detached.The procedure was completed with a new endovive safety peg kit pull method.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 with no injury.
 
Manufacturer Narrative
A visual examination of the returned device revealed that the feeding tube was broken approximately at 2cm from the dome.It was noted that the condition of the returned unit was consistent with the reported event of feeding tube detached/separated.It is most likely that the cause of the separation was that excessive force was applied during placement, while pulling the tube through the incision.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Based on the information available and the analysis performed, the most probable cause for the complaint will be documented as "operational context", probably due to anatomical/procedural factors encountered during the procedure, performance was limited.
 
Event Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during a gastrostomy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the tube was slightly pulled to check if it was properly and snugly placed, the peg tube detached.The procedure was completed with a new endovive safety peg kit pull method.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 with no injury.
 
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Brand Name
ENDOVIVE¿ SAFETY PEG KIT
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS 
MDR Report Key7593659
MDR Text Key110850936
Report Number3005099803-2018-01988
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
PMA/PMN Number
K031538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 05/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00566521
Device Catalogue Number6652
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2018
Date Manufacturer Received06/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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