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

Model Number M00568470

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was under 18 years old.(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 a one step button initial placement gastrostomy kit was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2015.According to the complainant, post procedure, when water was injected into the gastrostomy tube using a bolus feeding adaptor, resistance was met.It was exchanged with gastric decompression tube and there was difficulty when trying to let the air out of the stomach.Both devices didn't have any issue.The gastrostomy tube was removed and it was noticed that there was a black foreign object, like seed, inside the button dome.On (b)(6) 2015, the gastrostomy tube was replaced with a different device.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 good.

Manufacturer Narrative

The visual examination of the returned button, bolus feeding set and decompression tube revealed no visible issues with the components.Presence of residue was noted on the components, indicating use/handling.The bolus feeding adaptor had been inserted into the button upon receipt at cis.A functional evaluation was performed by inserting a 60cc syringe filled with water into the proximal connector of the bolus feeding set and injecting water through the button.No leaks or blockage were noted.A vacuum was then pulled and the button body collapsed; the reflux valve held as expected.A second functional evaluation was performed by pulling a vacuum in the system.The button body collapsed and reflux valve held.The syringe was then placed into the decompression tube and water was injected; no blockage was noted.The decompression tube adaptor was inserted into the button and the reflux valve opened properly.No issue was noted with any of the components.It was noted that the condition of the returned unit was not consistent with the complaint incident that the feeding tube was blocked/occluded, the reflex valve damaged and presence of a foreign object inside the components.Therefore, the complaint failure mode (feeding tube blocked / occluded) was not confirmed.A device history record (dhr) review of lot number 17619899 was performed and revealed no issues related to the reported complaint.

Event Description

It was reported to boston scientific corporation that a one step button initial placement gastrostomy kit was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2015.According to the complainant, post procedure, when water was injected into the gastrostomy tube using a bolus feeding adaptor, resistance was met.It was exchanged with gastric decompression tube and there was difficulty when trying to let the air out of the stomach.Both devices didn't have any issue.The gastrostomy tube was removed and it was noticed that there was a black foreign object, like seed, inside the button dome.On (b)(6) 2015, the gastrostomy tube was replaced with a different device.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 good.

• 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: 5014252
• MDR Text Key: 23437473
• Report Number: 3005099803-2015-02252
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• PMA/PMN Number: K910584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: M00568470
• Device Catalogue Number: 6847
• Device Lot Number: 17619899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• 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