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

Model Number	M00566480
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4) physician pulls device out of patient during initial placement.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 safety kit pull method was used during an esophagogastroduodenoscopy procedure.The procedure date is unknown.According to the complainant, during the procedure, as they pulled the peg tube through the stoma site, the peg tube came all the way from the stoma site out of the patient.Reportedly, the incision site was approximately 1.5 cm and the bolster was not able to anchor when they pulled the device.The procedure was completed with a new endovive safety kit pull method.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.
Additional Manufacturer Narrative
The complaint sample was inspected and analyzed.It was found out that the sample was within specification.It was noted that the condition of the returned device could not be evaluated with respect to feeding tube being pulled through the stoma site during initial placement.The complaint is due to a known physiological effect of the procedure noted within the directions for use.Based on all gathered information, the most probable root cause is "anticipated procedural complication." a search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety kit pull method was used during an esophagogastroduodenoscopy procedure.The procedure date is unknown.According to the complainant, during the procedure, as they pulled the peg tube through the stoma site, the peg tube came all the way from the stoma site out of the patient.Reportedly, the incision site was approximately 1.5 cm and the bolster was not able to anchor when they pulled the device.The procedure was completed with a new endovive safety kit pull method.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.

• 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: 6095528
• Report Number: 3005099803-2016-03414
• Device Sequence Number: 10834784
• Product Code: KNT
• UDI-Device Identifier: 08714729748403
• UDI-Public: (01)08714729748403(17)20180430(10)19539493
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 10/21/2016

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: 04/30/2018
• Device Model Number: M00566480
• Device Catalogue Number: 6648
• Device Lot Number: 19539493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2016
• Supplement Report FDA Received Date: 01/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1