MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ENDOVIVE¿ ONE STEP BUTTON¿; TUBE, GASTRO-ENTEROSTOMY

Model Number M00568530

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2017

Event Type  malfunction  

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that an endovive¿ one step button kit was used during a percutaneous endoscopic gastrostomy (peg) procedure performed on (b)(6) 2017.According to the complainant, post procedure, after the decompression tube was connected to the button, it was noticed that decompression was not performed as it was blocked/occluded.The endovive¿ one step button is still in use.There were no patient complications reported due to this event.The patient's condition at the conclusion of the procedure was reported to be with no problem.

Event Description

It was reported to boston scientific corporation that an endovive¿ one step button kit was used during a percutaneous endoscopic gastrostomy (peg) procedure performed on (b)(6) 2017.According to the complainant, post procedure, after the decompression tube was connected to the button, it was noticed that decompression was not performed as it was blocked/occluded.The endovive¿ one step button is still in use.There were no patient complications reported due to this event.The patient's condition at the conclusion of the procedure was reported to be with no problem.Correction as of (b)(4) 2017.They were able to perform decompression after the decompression tube was replaced to a new one.

• Brand Name: ENDOVIVE¿ ONE STEP BUTTON¿
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6322776
• MDR Text Key: 67258063
• Report Number: 3005099803-2017-00404
• 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
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: M00568530
• Device Catalogue Number: 6853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1