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

Model Number	M00509071
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	01/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit push method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure on (b)(6) 2022.During the procedure, the peg tube detached at the transition zone between the hard and soft plastic in the gastric wall and stoma incision.The procedure was not completed, and patient was sent for exploratory laparotomy surgery.It was reported that patient was admitted to hospital beyond the standard of care and was expected to fully recover.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and 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.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit push method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure on (b)(6) 2022.During the procedure, the peg tube detached at the transition zone between the hard and soft plastic in the gastric wall and stoma incision.The procedure was not completed, and patient was sent for exploratory laparotomy surgery.It was reported that patient was admitted to hospital beyond the standard of care and was expected to fully recover.
Additional Manufacturer Narrative
Block h6 (device codes): device problem code a0501 captures the reportable event of peg tube detached.Block h6 (impact codes): impact code f19 captures the reportable event of surgical intervention.Impact code f08 captures the reportable event of prolonged hospitalization.Block h10: an endovive standard peg push tube was returned.Product analysis found the peg tube separated from the dilator at the barbed connector joint.Visual assessment was performed on the joint where the peg tube meets the rigid tubing.It was noted that striations were visible on the rigid tubing indicating that it was likely subjected to a stretching force, resulting in the separation of the rigid tubing from the peg tube.The reported complaint was confirmed.Based on the condition of the returned device, engineers determined that the problem observed is likely operational factors, such as user technique/handling, patient anatomy, and the size of the incision site that the tube was being pulled through contributed to the reported complaint.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.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.

• Brand Name: ENDOVIVE STANDARD 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13359849
• Report Number: 3005099803-2022-00235
• Device Sequence Number: 4646454
• Product Code: PIF
• UDI-Device Identifier: 08714729880530
• UDI-Public: 08714729880530
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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: 09/25/2022
• Device Model Number: M00509071
• Device Catalogue Number: 57706
• Device Lot Number: 0027754776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• 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: Hospitalization
• Patient Sex: Unknown