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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Renal Failure (2041); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 07/01/2019

Event Type  Injury  

Event Description

It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that a dakota was used during a removal, calculus, ureter, ureteroscopic procedure performed on (b)(6) 2019.The patient was readmitted due to aki (acute kidney injury).

Manufacturer Narrative

Date of event: the exact date of the event is unknown.The provided event date was chosen as the best estimate based on the reported date of (b)(6) 2019.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).

• Brand Name: DAKOTA
• Type of Device: 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: 16265936
• MDR Text Key: 308398328
• Report Number: 3005099803-2023-00319
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Race: White