MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ENDOVIVE¿ STANDARD PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00568211

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual examination of the returned push g-tube found that the tip was damaged and appeared to be melted and had burn marks.The guidewire was not returned for analysis.The complaint kinked guidewire could not be verified because the guidewire was not returned.The customer only returned the push g-tube.It was noted that the condition of the returned unit was not consistent with the complaint incident that the tube was kinked.However, it was found that the tip of tube as damaged which could be an indicative that the peg tube had difficulty placing/retracting.Based on all gathered information, the investigation fails to determine a definite root cause.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.

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit push method was used during a percutaneous endoscopic gastrostomy tube placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, it was noted that the peg tube was kinked and would not pass over the guidewire.The guidewire was also noted to be kinked.The procedure was completed with a new endovive standard peg kit push method.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 fine.Investigation results revealed on (b)(6) 2017 that the tip of the peg tube was damaged which appeared to have melted and had burn marks.

• Brand Name: ENDOVIVE¿ STANDARD PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 6808162
• MDR Text Key: 83219794
• Report Number: 3005099803-2017-02555
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729285205
• UDI-Public: (01)08714729285205(17)20181130(10)20413124
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031538
• 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
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: M00568211
• Device Catalogue Number: 6821
• Device Lot Number: 20413124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2017
• 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