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

Model Number	DGN-538-5
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(4).Analysis of the returned device revealed that the device was returned without the net, however, it was inspected under magnification and residues of the net are still attached to the loop.Per complaint information, the issue occurred during the procedure, inside the patient.Probably procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.It is most likely that during procedure the device could have been manipulated, since the failure found is an issue that could have been generated by excessive manipulation of the device by the user.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
Event or Problem Description
It was reported to boston scientific corporation that a rescuenet retrieval net was used in the small intestine during a removal of capsule procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the net was torn while removing the capsule camera which was about 1.5cm long.Reportedly, there was no difficulty encountered in capturing the capsule and the rescuenet was not excessively manipulated to retrieve it.Just when the rescuenet was closed tight, the net was torn.In addition, the patient did not have any physiological issues.Another rescuenet retrieval net was used and the same issue occurred.The procedure was completed using a third rescuenet retrieval net.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the device returned without the net, however, it was inspected under magnification and residues of the net are still attached to the loop.

• Brand Name: RESCUENET
• Common Device Name: RETRIEVAL NET
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8209564
• Report Number: 3005099803-2018-62178
• Device Sequence Number: 1710155
• Product Code: FDI
• UDI-Device Identifier: 10840253107425
• UDI-Public: 10840253107425
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K152580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

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-538-5
• Device Catalogue Number: 50937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1