• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE ONE STEP BUTTON TUBE, GASTRO-ENTEROSTOMY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOVIVE ONE STEP BUTTON
Type of DeviceTUBE, GASTRO-ENTEROSTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key11665209
MDR Text Key245380296
Report Number3005099803-2021-01731
Device Sequence Number1
Product Code KGC
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K910584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/16/2021
Device Model NumberM00568630
Device Catalogue Number6863
Device Lot Number0022463083
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/14/2021 Patient Sequence Number: 1
-
-