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

Model Number	M00566491
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, while the physician was placing the peg tube, it detached inside the patient.The physician was able to retrieve the detached peg tube (unknown what method was used.) the procedure was completed with a new endovive safety 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
(patient identifier): csn: (b)(6).
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, while the physician was placing the peg tube, it detached inside the patient.The physician was able to retrieve the detached peg tube(unknown what method was used.) the procedure was completed with a new endovive safety 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 information received on april 5, 2018.They were able to pull the detached tube through the stoma site by hand.

• Brand Name: ENDOVIVE¿ SAFETY PEG KIT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7399019
• Report Number: 3005099803-2018-01124
• Device Sequence Number: 16226748
• Product Code: KNT
• UDI-Device Identifier: 08714729802655
• UDI-Public: 08714729802655
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: M00566491
• Device Lot Number: 20261299
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Weight: 120