MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ENDOVIVE¿ BUTTON RIGHT ANGLE FEEDING SET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	M00580181
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an endovive¿ button continuous right angle adaptor was connected to an endovive initial button which was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2017.According to the complainant, when the continuous right angle adaptor has been in use for about a day and a half after two days, it does not allow the medication syringes to stay attached.In addition when the continuous feed is being administered the feed comes back up the feeding adaptor tube.The patient¿s mother has tried taping it in there however that has not resolved the issue.She has also tried to resolve the issue by holding the adaptor, flushing it, disconnecting it, cleaning it, and did everything the physicians and the visiting nurse have instructed however this still did not resolve the issue.Reportedly, ¿these tubes do not come clean, these tubes clog.¿ there were times that her mother cleansed the tube using warm water with soap, diet coke, baking soda, and even tried toothpaste but still the feeding formula would either soak her daughter and the bed or spilled on the floor.It was also reported that the tube was very flimsy at the bottom and is not sturdy.According to the surgeon, the tube could not be changed right now as the stoma site still needs to undergo healing process.A replacement with a non-bsc tube is scheduled for (b)(6) 2017.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: ENDOVIVE¿ BUTTON RIGHT ANGLE FEEDING SET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6685616
• Report Number: 3005099803-2017-01985
• Device Sequence Number: 1736364
• Product Code: KNT
• UDI-Device Identifier: 08714729142249
• UDI-Public: (01)08714729142249(17)20191031(10)19953515
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/07/2017

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: 10/31/2019
• Device Model Number: M00580181
• Device Catalogue Number: 8018
• Device Lot Number: 19953515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 23