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

Model Number	DGN-538-5
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter's address is (b)(6).(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a rescuant retrieval net was prepared for use during a procedure performed on (b)(6) 2020.According to the complainant, during preparation and outside the patient, a hair-like foreign object was found inside the sterile pouch of the device before it was unpacked.The procedure was completed with another rescuant retrieval net.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block e1: the initial reporter's address is (b)(6).Block h6: problem code 2969 captures the reportable event of foreign material present in device packaging.Block h10: investigation results a rescuenet retrieval net was received for analysis.Visual inspection of the returned device revealed a hair inside the sealed package.No other issues were noted.Based on the event description, the problem was noticed during preparation and outside the patient.The presence of a foreign object (hair) was confirmed during product analysis and since the complaint investigation findings lead to problems traced to manufacturing process, the most probable root cause classification is manufacturing deficiency.There is an investigation in place to address this issue.A risk review of the rescuenet was completed and confirmed that the event of foreign matter was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a rescuenet retrieval net was prepared for use during a procedure performed on (b)(6) 2020.According to the complainant, during preparation and outside the patient, a hair-like foreign object was found inside the sterile pouch of the device before it was unpacked.The procedure was completed with another rescuenet retrieval net.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: RESCUENET
• Common Device Name: RETRIEVAL NET
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9721091
• Report Number: 3005099803-2020-00394
• Device Sequence Number: 10853123
• Product Code: FDI
• UDI-Device Identifier: 10840253107425
• UDI-Public: 10840253107425
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/24/2020

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 Expiration Date: 09/24/2022
• Device Model Number: DGN-538-5
• Device Catalogue Number: 50937
• Device Lot Number: 0024493892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1