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

Model Number	M00566491
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy placement procedure on (b)(6) 2022.During the procedure, when peg tube was being deployed over a guidewire, it separated into two pieces.It was reported that a gastroscope was utilized to retrieved the detached portion.The procedure was completed with a new endovive 20fr peg tube.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
This event was reported to the fda via a voluntary medwatch report.The report number is (b)(4).Device code: (b)(4).Impact code: (b)(4).Impact code: (b)4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block e4: this event was reported to the fda via a voluntary medwatch report.The report number is mw5106977.Block h6 (device codes): device code a0501 captures the reportable event of peg tube detached.Block h6 (impact codes) impact code f2301 captures the reportable event of additional device required.Impact code f23 captures the reportable event of unexpected medical intervention.Block h10: an endovive safety peg tube was returned.No defects were noted, the tubing was intact when it arrived.Visual assessment was performed on the joint where the peg tube meets the rigid tubing.No damage or defect was noted.Gentle pressure was applied to the joint by grasping the peg tube and rigid tubing in each hand and pulling them apart, but the peg tube would not detach from the joint.Therefore, the reported event of peg detached was not confirmed.Based on the condition of the returned device, engineers determined that product analysis was unable to find any defect with the returned device.Boston scientific has determined the most probable cause of this complaint is no problem detected.The correct complaint device was returned.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy placement procedure on (b)(6) 2022.During the procedure, when peg tube was being deployed over a guidewire, it separated into two pieces.It was reported that a gastroscope was utilized to retrieved the detached portion.The procedure was completed with a new endovive 20fr peg tube.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Common Device Name: 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 dr; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13776488
• Report Number: 3005099803-2022-01364
• Device Sequence Number: 19766499
• Product Code: KNT
• UDI-Device Identifier: 08714729802655
• UDI-Public: 08714729802655
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K031538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: M00566491
• Device Catalogue Number: 57700
• Device Lot Number: 0028109011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown