MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	M00509030
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	05/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 (date of event): date of event was approximated to (b)(6) 2023 as no event date was reported.Block h6 (device codes): imdrf device code a0501 captures the reportable event of peg tube detached.
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 procedure.The procedure date is unknown.It was reported that, during device placement, the peg tube tore apart.Reportedly, air leaked into the peritoneum requiring an angiocath to be inserted to release that air.The procedure was completed with a non-bsc device.
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 procedure.The procedure date is unknown.It was reported that, during device placement, the peg tube tore apart.Reportedly, air leaked into the peritoneum requiring an angiocath to be inserted to release that air.The procedure was completed with a non-bsc device.
Additional Manufacturer Narrative
Block b3 (date of event): date of event was approximated to 01may2023 as no event date was reported.Block h6 (device codes): imdrf device code a0501 captures the reportable event of peg tube detached.Block h10: an endovive safety peg kit push method was analyzed.Visual analysis of the device found that the peg tube separated from the introducer dilator tubing at the joint between the parts.In addition, the returned tubing was necked thin at the joint.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be related to operational factors, such as technique/handling, patient anatomy, the size of the incision site that the tube was being pulled through and an excessive force used during placement that stretched the tubing could have contributed to the reported complaint.In addition, an evidence to support this scenario includes product analysis details and by applying force to the introducer dilator tubing cause the material to neck down and thin.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported event.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17040235
• Report Number: 3005099803-2023-02807
• Device Sequence Number: 6393285
• Product Code: PIF
• UDI-Device Identifier: 08714729880448
• UDI-Public: 08714729880448
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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: 12/31/2023
• Device Model Number: M00509030
• Device Catalogue Number: 57707
• Device Lot Number: 0030201905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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 Age: 52 YR
• Patient Sex: Unknown