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

Model Number	DGN-538-5
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	08/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis; therefore, a problem 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 for food impaction in the esophagus/stomach during an endoscopy procedure performed on an unknown date.It was reported that during the procedure, the net was torn and got fully detached from the loop after capturing the foreign object.No issues were present upon opening the package.Reportedly, the detached piece was retrieved but it was unknown how it was retrieved.The procedure was completed with a different rescuenet.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable/fine.

• Brand Name: RESCUENET
• Common Device Name: RETRIEVAL NET
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12464006
• Report Number: 3005099803-2021-04728
• Device Sequence Number: 1245300
• Product Code: FDI
• UDI-Device Identifier: 10840253107425
• UDI-Public: 10840253107425
• 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): 09/13/2021

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-538-5
• Device Lot Number: 0026643363
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/13/2021
• 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