Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 LOW PROFILE REPLACEMENT BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  • 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 LOW PROFILE REPLACEMENT BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number M00568260
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).(b)(4).
 
Event Description
It was reported to boston scientific corporation that an endovive one step button used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2019.According to the complainant, during preparation, it was noticed that the device was broken (exactly where it is broken is unknown.) the procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be stable.
 
Manufacturer Narrative
(initial reporter phone): (b)(6).(device codes): problem code 2920 captures the reportable event of peg tube difficult to place.The analysis of the returned device revealed that the reported issue of feeding tube difficult to advance could not be functionally verified.Visual assessment of one endovive replacement button kit showed that the body of the button had a small tear; consequently, confirming the reported event of device was broken.No other issues were identified with the device.No foreign materials, air bubbles, voids were identified in the torn area indicating the material was formed properly, also the tear area seemed to be a regular tear made likely by a sharp tool or interaction with another device/instrument.It is most likely that the device was torn due to handling and manipulation of the button body during preparation.During manufacturing it was confirmed parts have no short shots or foreign material, first shots for correct length and french size on body per drawing and the part is inspected for flash per cosmetic inspection procedure, this part of the process would have detected the torn section of the device.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
 
Event Description
It was reported to boston scientific corporation that an endovive one step button used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2019.According to the complainant, during preparation, it was noticed that the device was broken (exactly where it is broken is unknown.) the procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDOVIVE LOW PROFILE REPLACEMENT BUTTON
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8937101
MDR Text Key155819482
Report Number3005099803-2019-04293
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/20/2021
Device Model NumberM00568260
Device Catalogue Number6826
Device Lot Number0022841089
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2019
Initial Date Manufacturer Received 07/31/2019
Initial Date FDA Received08/27/2019
Supplement Dates Manufacturer Received10/30/2019
Supplement Dates FDA Received11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age2 YR
-
-