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

Model Number	M00568201
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation during a stock check in the supply room it was noted that an endovive standard peg kit pull method had a lidocaine leak.This event has been deemed a reportable event based on the investigation results: packaging contaminated.
Additional Manufacturer Narrative
Date of event : date of event was approximated to (b)(6) 2022 as no event date was reported.(b)(4).The returned endovive standard peg kit was analyzed.Product analysis found the kit returned sealed with a brown residue noted inside.The kit was opened and visual inspection was conducted on all internal components: no damage or defect was noted with any of the devices inside the kit.None of the components that contained liquid had any leaks or evidence of damage.Based on the condition of the returned device, engineers determined that the problem observed is most probable that the source of the brown residue came from external to the kit, possibly another product that leaked onto the complaint device in storage.Boston scientific has determined the most probable cause of this complaint is cause traced to transport/storage, which indicates that the problems are traced to inappropriate transport or storage of the device.

• 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
• 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: 15350507
• Report Number: 3005099803-2022-05021
• Device Sequence Number: 5863673
• Product Code: KNT
• UDI-Device Identifier: 08714729285199
• UDI-Public: 08714729285199
• Combination Product (Y/N): Y
• Initial Reporter State: RI
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2024
• Device Model Number: M00568201
• Device Catalogue Number: 6820
• Device Lot Number: 0029173872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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
• Patient Sex: Unknown