MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONE CONE; DISLODGER, STONE, FLEXIBLE

Model Number M0063903200

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a nitinol retrieval basket was used during the right transurethral lithotripsy (tul) procedure in the ureter performed on (b)(6) 2024.During the procedure, when the stone cone was placed, a small portion of unknown length as torn off from the straight impermeable marker at the tip and remained in the ureter or retroperitoneum after repeated manipulation due to ureteral stricture.The broken piece was unable to be retrieved; however, a stent was placed, and the procedure was completed.It was stated that the patient had an injury.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of coil detachment or device component.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Imdrf patient code e2401 captures the reportable event of unspecified patient injury.Imdrf impact code f2301 captures the reportable event of additional device required.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a040506 captures the reportable event of coil peeled.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Imdrf impact code f2301 captures the reportable event of additional device required.Block h10: additional information updated b5: describe event or problem correction to field block b1: adverse event/product problem correction to field block b2: outcomes attrib to adv event correction to field block h1: type of reportable event correction to field block h6: patient codes and device codes.

Event Description

It was reported that a nitinol retrieval basket was used during the right transurethral lithotripsy (tul) procedure in the ureter performed on (b)(6), 2024.During the procedure, when the stone cone was placed, the distal tip was torn and detached from the impermeable marker and remained in the ureter or retroperitoneum after repeated manipulation due to ureteral stricture.The broken piece was unable to be retrieved; however, a stent was placed, and the procedure was completed.It was reported that the broken piece is expected to be removed.There were no patient complications reported as a result of this event.

• Brand Name: STONE CONE
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): LAKE REGION MEDICAL; 31c butterfield trail; el paso TX 79906
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18950621
• MDR Text Key: 338254030
• Report Number: 2124215-2024-17165
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/22/2024
• 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