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

Model Number M00563030

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

(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 Description

It was reported to boston scientific corporation that an endovive one step button was used during an esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the pull wire detached from the one step button tube and fell off in the stomach.The detached portion was retrieved using a snare.Reportedly, patient went to surgery to have different feeding tube placed.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.

Manufacturer Narrative

A visual examination of the returned device revealed that the catheter was separated into two pieces, confirming the complaint.The damaged section of the catheter appeared elongated.It is likely that excessive tension resulted in the damage.It was noted that the condition of the returned unit was consistent with the complaint incident the button tube delivery system became detached/separated.Based on all gathered information, the complaint investigation conclusion code selected is operational context, which indicates that the complaint is associated with a product that meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.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.A labeling review was performed and there is no evidence that the device was not used in accordance with the labeling.

Event Description

It was reported to boston scientific corporation that an endovive one step button was used during an esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the pull wire detached from the one step button tube and fell off in the stomach.The detached portion was retrieved using a snare.Reportedly, patient went to surgery to have different feeding tube placed.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.

• Brand Name: ENDOVIVE¿ ONE STEP BUTTON¿
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7494195
• MDR Text Key: 107586141
• Report Number: 3005099803-2018-01516
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 08714729284161
• UDI-Public: 08714729284161
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: M00563030
• Device Catalogue Number: 6303
• Device Lot Number: 20604355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR