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

Model Number M00563030

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2015

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a one step button initial placement gastrostomy kit was used during a procedure performed on (b)(6) 2015.According to the complainant, the enteral supplement had to be administered via syringe with a plunger because it would not flow via gravity.The procedure was completed with this one step button initial placement gastrostomy kit.The patient's condition at the conclusion of the procedure was reported to be okay.

Manufacturer Narrative

The reported lot number could not be matched to the reported device.Therefore, the lot expiration and device manufacture dates are unknown at this time.(b)(4) feeding tube blocked/occluded.The complainant indicated that the device will not be returned for evaluation as it is implanted in the patient; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 4524777
• MDR Text Key: 5538963
• Report Number: 3005099803-2015-00378
• Device Sequence Number: 1
• Product Code: KGC
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00563030
• Device Catalogue Number: 6303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1