MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ENDOVIVE¿ STANDARD PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	M00568251
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code relates to component code for the reported event of peg tube detached/separated.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 standard peg kit push method was used during a percutaneous endoscopic gastrostomy placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, when the peg tube was pulled out of the stoma site, it detached at the transition zone between the hard and soft plastic.The procedure was completed with a new endovive standard peg kit push method.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
A visual examination of the feeding tube found that it was not separated.The connector is properly formed.The connector and the inner ring are inside the silicone tubing.The outer ring is in place.The tubing is slightly bent, most probably from being coiled for return, and is not distended.It was noted that the condition of the returned unit was not consistent with the complaint incident that the feeding tube was detached and separated.Based on all gathered information which showed no evidence of either the alleged issue or any defect which could have contributed to the event, the assigned cause is "not confirmed - returned".A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit push method was used during a percutaneous endoscopic gastrostomy placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, when the peg tube was pulled out of the stoma site, it detached at the transition zone between the hard and soft plastic.The procedure was completed with a new endovive standard peg kit push method.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: ENDOVIVE¿ STANDARD PEG KIT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7032997
• Report Number: 3005099803-2017-03464
• Device Sequence Number: 13805620
• Product Code: KNT
• UDI-Device Identifier: 08714729296805
• UDI-Public: 08714729296805
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K031538
• 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,Followup
• Report Date (Section B): 10/27/2017

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: 04/30/2019
• Device Model Number: M00568251
• Device Catalogue Number: 6825
• Device Lot Number: 20673250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1