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

Model Number DGN-538-5

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2018

Event Type  malfunction  

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 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
• Type of Device: RETRIEVAL NET
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): MICROTECH; no 10 gaoke third road; national new and high; nanjing ; CH
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8209564
• MDR Text Key: 131832419
• Report Number: 3005099803-2018-62178
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 10840253107425
• UDI-Public: 10840253107425
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K152580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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