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

Model Number M00568211

Device Problems Obstruction of Flow (2423); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 (device codes): imdrf device code a1409 captures the reportable event of peg tube obstructed.

Event Description

Note: this report pertains to the second of two endovive standard peg kit push method used during the same procedure.It was reported to boston scientific corporation that an endovive standard peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) insertion procedure performed on (b)(6) 2023.It was reported that the guidewire would not pass through the peg tube.A second peg kit was opened and had the same problem.The procedure was completed with a third endovive standard peg kit push method.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): imdrf device code a1409 captures the reportable event of peg tube obstructed.Block h10: the returned endovive standard peg kit push was analyzed.Visual inspection revealed no signs of damage or obstruction within the tubing.Additionally, it was found that the hypotube in the connector between the thermoformed tubing and feeding tube was obstructed with adhesive and guidewire could not pass through.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of peg tube obstruction was confirmed during the product investigation.Based on the condition of the returned device, it is probable that the problem occurred due to incorrect placement or excessive use of adhesive during manufacturing process, causing the coding to obstruction of the hypotube.Therefore, the most probable root cause is manufacturing deficiency.An investigation to address this problem is in progress.

Event Description

Note: this report pertains to the second of two endovive standard peg kit push method used during the same procedure.It was reported to boston scientific corporation that an endovive standard peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) insertion procedure performed on (b)(6) 2023.It was reported that the guidewire would not pass through the peg tube.A second peg kit was opened and had the same problem.The procedure was completed with a third endovive standard peg kit push method.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE STANDARD PEG KIT
• 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: 18107051
• MDR Text Key: 328491472
• Report Number: 3005099803-2023-06107
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729285205
• UDI-Public: 08714729285205
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K031538
• 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,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00568211
• Device Catalogue Number: 6821
• Device Lot Number: 0032151880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• 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