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

Model Number	M00568201
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure 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 pull method used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2021.During procedure, it was noted the needle would not exit the trocar.The trocar was damaged.It was reported the patient experienced discomfort.The procedure was stopped.On the same day the patient had another peg tube surgically placed.The condition of the patient was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6 (impact code): code f19 captures the reportable event of surgical intervention.Block h10: an endovive standard peg pull trocar was returned.Visual analysis of the trocar revealed that the sheath was deformed at the distal tip.The reported complaint was confirmed.Based on the condition of the returned device, engineers determined that the failure mode was caused by handling of the device during use.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 on the endovive standard peg kit instructions for use (ifu).There was no evidence that the device was used in a manner inconsistent with the labeled indications.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit pull method used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2021.During procedure, it was noted the needle would not exit the trocar.The trocar was damaged.It was reported the patient experienced discomfort.The procedure was stopped.On the same day the patient had another peg tube surgically placed.The condition of the patient was reported to be fully recovered.

• Brand Name: ENDOVIVE STANDARD PEG KIT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12024999
• Report Number: 3005099803-2021-02964
• Device Sequence Number: 4269798
• Product Code: KNT
• UDI-Device Identifier: 08714729285199
• UDI-Public: 08714729285199
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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: 10/22/2022
• Device Model Number: M00568201
• Device Catalogue Number: 6820
• Device Lot Number: 0027198829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 08/01/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR
• Patient Weight: 80