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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ENDOVIVE¿ SECURI-T¿; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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BOSTON SCIENTIFIC - COSTA RICA (COYOL) ENDOVIVE¿ SECURI-T¿; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number M00568151
Device Problems Detachment Of Device Component (1104); Human-Device Interface Problem (2949)
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.(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 an endovive¿ securi-t¿ percutaneous replacement gastrostomy tube used during a gastrostomy replacement procedure.The procedure date is unknown.According to the complainant, the device was removed in less than a month since it was placed.Reportedly when it was found the tube was in the patient¿s hand.It is unknown if the patient pulled out the tube.The bolster was missing from the tube and it is unknown if it detached inside or outside the patient's body.There were no patient complications reported due to this event.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.
 
Manufacturer Narrative
A visual examination of the returned device revealed that the internal bolster was found to be separated from the device.Remnants of the bolster remain on the end of the tubing.The distal end of the tubing presented no tearing.There were no defects found in the internal bolster that might have contributed to the failure.It appears that the internal bolster was securely molded to the tubing.The complaint was consistent with the reported incident that the bolster detached/separated.The bolster failure appeared to have occurred while undergoing shear force during removal from the patient.Bolster detachment during removal most likely occurred because excess force was applied to the device during removal causing the bond between the tubing and bolster fail.Therefore, taking into consideration all this factors and the condition of the returned product, the most probable cause of this complaint will be documented as ¿operational context¿ since it is most likely that due to anatomical and/or procedural factors encountered during the procedure the performance of the device was limited.
 
Event Description
It was reported to boston scientific corporation that an endovive¿ securi-t¿ percutaneous replacement gastrostomy tube used during a gastrostomy replacement procedure.The procedure date is unknown.According to the complainant, the device was removed in less than a month since it was placed.Reportedly when it was found the tube was in the patient¿s hand.It is unknown if the patient pulled out the tube.The bolster was missing from the tube and it is unknown if it detached inside or outside the patient's body.There were no patient complications reported due to this event.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.
 
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Brand Name
ENDOVIVE¿ SECURI-T¿
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 Key7609532
MDR Text Key111450053
Report Number3005099803-2018-02006
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
PMA/PMN Number
K961345
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00568151
Device Catalogue Number6815
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2018
Date Manufacturer Received06/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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