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

Model Number	M00568530
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(b)(4).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 one step button was used during a gastrostomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after connecting the insertion wire to the loop on the endovive one step button, as the catheter was being pulled out from the abdomen reportedly, the tube button got broken.The physician tried to place only the remaining button part however it detached in the stomach.The detached portion was retrieved with the endoscope.The procedure was completed with a new endovive one step button.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(b)(4).Visual examination of the returned device revealed that the sheath was peeled away and the button was partially released.The c-flex tubing was broken approximately 1cm of the tubing remained on the distal end of the connector.The c-flex tubing was narrowed near the broken area indicating stretching of material due to tensile force and the broken area was found irregular.The c-flex tubing outer diameter was measured in some points of the device and the narrowed section was found out of specification.The complaint was consistent with the reported incident that the feeding tube was detached.It is most likely that procedural and anatomical factors encountered during the procedure could have affected the device performance and its integrity.Based on the information available and the analysis performed, the investigation conclusion code for the complaint will be documented as adverse event related to procedure since 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.
Event or Problem Description
It was reported to boston scientific corporation that an endovive one step button was used during a gastrostomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after connecting the insertion wire to the loop on the endovive one step button, as the catheter was being pulled out from the abdomen reportedly, the tube button got broken.The physician tried to place only the remaining button part however it detached in the stomach.The detached portion was retrieved with the endoscope.The procedure was completed with a new endovive one step button.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: 8528365
• Report Number: 3005099803-2019-02020
• Device Sequence Number: 1884316
• Product Code: KGC
• UDI-Device Identifier: 08714729149941
• UDI-Public: 08714729149941
• 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
• Report Date (Section B): 06/03/2019

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 Model Number: M00568530
• Device Catalogue Number: 6853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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: Other