MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESCUENET; RETRIEVAL NET

Model Number	DGN-538
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	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a rescuenet retrieval net was used during a gastroscopy procedure performed on an unknown date.During the procedure, while attempting to retrieve an object from a child's stomach, they were to capture the object in the rescue net and had pulled out to about the throat area when the netting separated from the snare portion, dropping the object near the airway.The object was able to be grabbed with instruments before it could go down any further.It is unknown how the detached net was retrieved.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

• Brand Name: RESCUENET
• Common Device Name: RETRIEVAL NET
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12174340
• Report Number: 3005099803-2021-03539
• Device Sequence Number: 13680307
• Product Code: FDI
• UDI-Device Identifier: 00840253107428
• UDI-Public: 00840253107428
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K152580
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 01/15/2024
• Device Model Number: DGN-538
• Device Catalogue Number: DGN-538
• Device Lot Number: 0026643363
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/15/2021
• 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: Required Intervention