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 Problem Perforation (2001)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the reported date of (b)(6) 2017.The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).

Event Description

It was reported to boston scientific corporation that a dakota basket was used during a removal, calculus, ureter, ureteroscopic procedure performed in (b)(6) 2017.During procedure, ureteral perforation occurred.A stent was implanted, and the procedure was aborted.

Event Description

It was reported to boston scientific corporation that a dakota basket was used during a removal, calculus, ureter, ureteroscopic procedure performed in (b)(6) 2017.During procedure, ureteral perforation occurred.A stent was implanted, and the procedure was aborted.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the reported date of (b)(6) 2017.Block d4, h4: the complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.Block h6: patient code e2114 captures the reportable event of ureteral perforation.Impact code f2301 captures the reportable event of stent placement.

• 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; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16253603
• MDR Text Key: 308258575
• Report Number: 3005099803-2023-00289
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• 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: 03/06/2023
• 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
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White