MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESCUENET RETRIEVAL NET

Model Number	DGN-538
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the upn and device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a rescuenet retrieval net was used in the stomach and esophagus to remove a food bolus during an esophagogastroduodenoscopy (egd) procedure performed on an unknown date.According to the complainant, during the procedure and inside the patient, it was reported that the net was fully detached from the outer ring and the net was not retrieved from inside the patient.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

• Brand Name: RESCUENET RETRIEVAL NET
• Common Device Name: RETRIEVAL NET
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10627149
• Report Number: 3005099803-2020-04357
• Device Sequence Number: 3204967
• Product Code: FDI
• UDI-Device Identifier: 00840253107428
• UDI-Public: 00840253107428
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K152580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2020

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 Model Number: DGN-538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1