MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DAKOTA; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063905000
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 dakota was to be used in a lithotripsy procedure performed on (b)(6) 2022.During preparation, it was found that the tape used to seal the shipping box was also taped on the sterile packaging which lead to the sterile packaging being damaged.The procedure was completed with another dakota.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Block h6: device code a0205 captures the reportable event of packaging damaged.Block h10: the returned dakota basket was analyzed, and a visual evaluation observed that the device was inside the original pouch and was unopen.The pouch has a tear and the seal of the pouch is not compromised.Based on all available information, the most probable root cause cannot be established since the investigation findings do not lead to a clear conclusion about the cause of the reported event.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.The complaint was not created due to any spencer manufacturing issue, it is believed this failure was cause due to incorrect handling of the product outside of our control.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a dakota was to be used in a lithotripsy procedure performed on (b)(6), 2022.During preparation, it was found that the tape used to seal the shipping box was also taped on the sterile packaging which lead to the sterile packaging being damaged.The procedure was completed with another dakota.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: DAKOTA
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14110954
• Report Number: 3005099803-2022-02055
• Device Sequence Number: 6229704
• Product Code: FFL
• UDI-Device Identifier: 08714729937364
• UDI-Public: 08714729937364
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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: 03/02/2025
• Device Model Number: M0063905000
• Device Catalogue Number: 63057
• Device Lot Number: 0028980012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown