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

Model Number M00568530

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

Event Type  malfunction  

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 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.

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 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
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9744531
• MDR Text Key: 190606951
• Report Number: 3005099803-2020-00549
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 08714729149941
• UDI-Public: 08714729149941
• Combination Product (y/n): N
• PMA/PMN Number: K910584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1