MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE ONE STEP BUTTON; TUBE, GASTRO-ENTEROSTOMY

Model Number	M00568520
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an endovive one step button kit pull method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2019.According to the complainant, during the procedure, when the device was pulled from the inside out of the stoma, the catheter had detached.Reportedly, there was no resistance encountered when it was pulled.The procedure was completed with a new endovive one step button kit pull method.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an endovive one step button kit pull method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2019.According to the complainant, during the procedure, when the device was pulled from the inside out of the stoma, the catheter had detached.Reportedly, there was no resistance encountered when it was pulled.The peg tube detached inside patient and the detached portion was retrieved via endoscope.The procedure was completed with a new endovive one step button kit pull method.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code 2907 captures the reportable event of one step button detached.Block h10: the analysis of the returned device revealed that the sheath peeled away and the button completely released.The c-flex tubing was broken.Approximately 1cm of the tubing remained on the distal end of the connector.The c-flex tubing is narrowed near the broken area indicating stretching of material due to tensile force.C-flex tubing outer diameter was measured in some points of the device, the narrowed section was found out of specification confirming stretching of material.The complaint was consistent with the reported incident that one step button delivery system was detached.It is most likely that procedural and anatomical factors encountered during the procedure could have affected the device performance and its integrity.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.
Additional Manufacturer Narrative
Block h6 (device codes): problem code 2907 captures the reportable event of one step button detached.Block h6 (evaluation conclusion codes): 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an endovive one step button kit pull method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2019.According to the complainant, during the procedure, when the device was pulled from the inside out of the stoma, the catheter had detached.Reportedly, there was no resistance encountered when it was pulled.The peg tube detached inside patient and the detached portion was retrieved via endoscope.The procedure was completed with a new endovive one step button kit pull method.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE ONE STEP BUTTON
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8935075
• Report Number: 3005099803-2019-04285
• Device Sequence Number: 1746805
• Product Code: KGC
• UDI-Device Identifier: 08714729149231
• UDI-Public: 08714729149231
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2019

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: 12/09/2021
• Device Model Number: M00568520
• Device Catalogue Number: 6852
• Device Lot Number: 0023169946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/26/2019; 09/23/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 08/29/2019; 10/18/2019
• 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: Required Intervention