MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESCUENET; SNARE, FLEXIBLE

Model Number	DGN-538-5
Medical Device Problem Codes	Use of Device Problem (1670); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a rescuenet retrieval net was to be used to place an endoscopy pill camera during an esophagogastroduodenoscopy procedure performed on (b)(6) 2022.During the procedure, the physician attempted to place a 26mm endoscopy pill camera using the rescuenet.The pill camera was placed in the rescuenet and the net was closed.While passing the scope and device with the enclosed pill camera through the bite block, the net tore and the pill cam was lost in the throat of the patient.There was difficulty retrieving the pill cam and the patient became at risk.The procedure was cancelled, and the patient went to surgery to have the pill cam removed.The patient was admitted to the hospital beyond the standard of care and has been discharged.No further information has been obtained despite good faith efforts.Note: the rescuenet was being used to place an endoscopy pill camera; however, the rescuenet retrieval net is indicated for use in endoscopic retrieval of foreign objects, food bolus, tissue fragments and excised tissue such as polyps.The device is not indicated to place endoscopy pill cameras.

• Brand Name: RESCUENET
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16268092
• Report Number: 3005099803-2023-00018
• Device Sequence Number: 6390755
• Product Code: FDI
• UDI-Device Identifier: 10840253107425
• UDI-Public: 10840253107425
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K152580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2025
• Device Model Number: DGN-538-5
• Device Catalogue Number: DGN-538-5
• Device Lot Number: 0030369537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown