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

Model Number DGN-538-5

Device Problems Use of Device Problem (1670); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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
• Type of Device: 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
• MDR Text Key: 308440528
• Report Number: 3005099803-2023-00018
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 10840253107425
• UDI-Public: 10840253107425
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization