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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE ONE STEP BUTTON; TUBE, GASTRO-ENTEROSTOMY
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE ONE STEP BUTTON; TUBE, GASTRO-ENTEROSTOMY Back to Search Results
Model Number M00568630
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 03/01/2021
Event Type  Injury  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(initial reporter facility name): (b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that an endovive one step button was placed during a gastrostomy placement procedure performed on (b)(6) 2021.The procedure was completed with this device.It was reported that sometime in (b)(6) (the exact date is unknown), the patient's condition deteriorated.Upon examination subcutaneous emphysema was confirmed around the cricopharynx.In the physician's assessment during the gastrostomy procedure the guidewire may have become deflected and got caught at the oral cavity.Therefore inadvertently causing a perforation which lead to subcutaneous emphysema.The hospital could not give any treatment to address the emphysema, the patient was sent to another hospital for further follow-up.The exact treatment given is unknown.The patient is currently under observation.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Event Description
It was reported to boston scientific corporation that an endovive one step button was placed during a gastrostomy placement procedure performed on (b)(6) 2021.The procedure was completed with this device.It was reported that sometime in march (the exact date is unknown), the patient's condition deteriorated.Upon examination subcutaneous emphysema was confirmed around the cricopharynx.In the physician's assessment during the gastrostomy procedure the guidewire may have become deflected and got caught at the oral cavity.Therefore inadvertently causing a perforation which lead to subcutaneous emphysema.The hospital could not give any treatment to address the emphysema, the patient was sent to another hospital for further follow-up.The exact treatment given is unknown.The patient is currently under observation.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received on april 26, 2021: it was reported that during the procedure, there was no trauma noted in the esophagus.Computed tomography (ct) scan was performed to confirm a peroration and to determine the location.In addition, it was reported that the scope was used during the procedure to confirm placement of device however was not used after placement.The patient remains under observation.
 
Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block e1 (initial reporter facility name): (b)(6) memorial hospital.Block h6 (patient codes): patient code e2114 captures the reportable event of perforation.Block h6 (evaluation conclusion codes): conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
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Brand Name
ENDOVIVE ONE STEP BUTTON
Type of Device
TUBE, GASTRO-ENTEROSTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11665209
MDR Text Key245380296
Report Number3005099803-2021-01731
Device Sequence Number1
Product Code KGC
Combination Product (y/n)Y
PMA/PMN Number
K910584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/16/2021
Device Model NumberM00568630
Device Catalogue Number6863
Device Lot Number0022463083
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/22/2021
Initial Date FDA Received04/14/2021
Supplement Dates Manufacturer Received04/26/2021
Supplement Dates FDA Received04/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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