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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number M00566521
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2019
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 at this time.(b)(6).(b)(4).Evaluation conclusion codes: the device has not been received for analysis.Upon receipt and 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 percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2019.According to the complainant, the procedure and the placement was performed without issue which was confirmed via the endoscope that the bolster part was properly placed in the stomach.On july 14, the feeding tube was found on the bedside.It is unknown if it was intentionally removed or it was removed by accident as the patient was bedridden.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2019.According to the complainant, the procedure and the placement was performed without issue which was confirmed via the endoscope that the bolster part was properly placed in the stomach.On july 14, the feeding tube was found on the bedside.It is unknown if it was intentionally removed or it was removed by accident as the patient was bedridden.There were no patient complications reported as a result of this event.Additional information received on 19sep2019: reportedly, the complaint device was replaced with a non bsc device.
 
Manufacturer Narrative
(investigation results): visula examination of the returned device revealed that the domed peg tube does not have any visual damage, the device is intact.The internal bolster/dome does not have any visible damage.The reported incident that the peg tube - patient removal could not be visually or functionally verified.As per complaint information the device was placed without issue for some days, this indicates that likely the device was unintentionally removed.Directions for use mentions "inadvertent removal" as a possible complication of the device usage.Therefore, the most probable cause of this complaint is known inherent risk of device since reported adverse event known and documented in the labeling.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(initial reporter facility name): (b)(6).(initial reporter city): (b)(6).(device codes): problem code 2949 captures the reportable event of peg tube intentional/unintentional patient removal.
 
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Brand Name
ENDOVIVE SAFETY PEG KIT
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8892875
MDR Text Key154268335
Report Number3005099803-2019-04079
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,foreig
Type of Report Initial,Followup
Report Date 10/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2019
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 Manufacturer08/14/2019
Date Manufacturer Received09/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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