MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE LOW PROFILE REPLACEMENT BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	M00562790
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(evaluation conclusion codes): code 4316 is being used in lieu of an adequate conclusion code for device not returned.
Event or Problem Description
It was reported to boston scientific corporation that an endovive low profile replacement button was used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2019.According to the complainant, during feedings and medication administration, the patient noted it would not stay down and kept coming back up though the port.Reportedly, a syringe with plunger were being used however when the syringe was taken out the contents would come out.The feeding tube was removed and was replaced with a non-bsc tube.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE LOW PROFILE REPLACEMENT BUTTON
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8845151
• Report Number: 3005099803-2019-03867
• Device Sequence Number: 16781328
• Product Code: KNT
• UDI-Device Identifier: 08714729284031
• UDI-Public: 08714729284031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K014297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: M00562790
• Device Catalogue Number: 6279
• Device Lot Number: 0023665906
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1