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

Model Number DGN-538-5

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to be (b)(6) 2018 as no event date was reported.(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a rescuenet retrieval net was used during a procedure performed on an unknown date.According to the complainant, during the procedure, when removing the bolus, it was noted that the net was torn.Reportedly, when they assessed for the missing net, it was noted that the net was embedded on the patient's esophagus.They used another retrieval device to retrieve the net.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.

• 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: 8102478
• MDR Text Key: 128296784
• Report Number: 3005099803-2018-61537
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2021
• Device Model Number: DGN-538-5
• Device Catalogue Number: 50937
• Device Lot Number: 0180519241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention