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

Model Number	M00568530
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(initial reporter city): (b)(6).(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 or Problem Description
It was reported to boston scientific corporation that an endovive one step button was used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2020.According to the complainant, during the procedure, when placing the button the bolster went through the stoma site and outside the patient without any resistance.The procedure was completed with a new endovive one step button (different size).There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1 (initial reporter city): (b)(6) block h6 (device codes): problem code 2923 captures the reportable event of peg tube dislodged.Block h10: visual examination of the returned device revealed the device returned did not present any visual damage or abnormalities.Additionally, the dimensional dome measured and the result is within specification.Therefore, based on all gathered information, it was concluded that the investigation conclusion code of this event will be documented as no problem detected since the device complaint or problem cannot be confirmed.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 or Problem Description
It was reported to boston scientific corporation that an endovive one step button was used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6), 2020.According to the complainant, during the procedure, when placing the button the bolster went through the stoma site and outside the patient without any resistance.The procedure was completed with a new endovive one step button (different size).There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE ONE STEP BUTTON
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9744531
• Report Number: 3005099803-2020-00549
• Device Sequence Number: 14074200
• Product Code: KGC
• UDI-Device Identifier: 08714729149941
• UDI-Public: 08714729149941
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2022
• Device Model Number: M00568530
• Device Catalogue Number: 6853
• Device Lot Number: 0024569471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1