MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE LOW PROFILE REPLACEMENT BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00568190

Device Problems Material Puncture/Hole (1504); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned endovive low profile replacement button was analyzed, and a visual evaluation noted that the replacement button dome presented a rupture.The device was observed under magnification and a rupture on the tip of the replacement button dome was noted.The obturator rod was also returned and it was in good condition without edges or roughness that could damage the replacement button dome.No other problems with the device were noted.The reported event was confirmed.Based on the condition of the returned device, separation of the device could possibly occur.Punctured button dome could have been generated if the obturator rod tip is placed into the replacement button dome and an excess force is used.The event happened during the procedure, so it is possible that the technique used in conjunction with the force may have caused the damage.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific that an endovive replacement button was used during a gastrostomy replacement procedure.The procedure date is unknown.On (b)(6) 2021, approximately two weeks after the gastrostomy replacement, it was noticed that the gastrostomy tube moved towards the abdominal surface, which required replacement.During the replacement procedure, when they extended the button of the device using the obturator, the button was punctured.The procedure was completed with a new endovive replacement button.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE LOW PROFILE REPLACEMENT BUTTON
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13053248
• MDR Text Key: 282586361
• Report Number: 3005099803-2021-07903
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2023
• Device Model Number: M00568190
• Device Catalogue Number: 6819
• Device Lot Number: 0027195961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2020
• 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