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

Model Number M0063903100

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of coil detached.Imdrf impact code f2301 captures the reportable event of additional device required.Block h10: investigation results the product was not returned for analysis to identify any defect with the device; however, media analysis shows that the coil was detached.The ifu stated, if resistance is encountered while attempting to withdraw the coil do not exert excessive force.To release the object from the device, advance the sheath to straighten the coil and remove the device.Based on the investigation results there is no evidence from the manufacturing review to indicate that a device malfunctioned because of a process related defect.Torquing and excessive force used while catching a stone within the patient are the likely cause of the reported event.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.

Event Description

It was reported to boston scientific corporation that a nitinol retrieval basket was used during a ureteroscopy procedure performed on (b)(6) 2024.During the procedure, the stone cone was used to avoid migration of the stones; however, it was noticed that one portion of the cone was still inside the patient.It was reported that the piece was removed inside the patient using a dakota basket.The procedure was completed with another nitinol retrieval basket.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of coil detached.Imdrf impact code f2301 captures the reportable event of additional device required.Block h10: investigation results: the returned nitinol retrieval coil was analyzed, and a visual evaluation noted that the coil was received in the open state.It was also noted that there was a tangle on the coil and the green/blue sheath above the coil had peeled off.Functional evaluation was performed, and when trying to open/ close the coil, the coil stopped at the area of the tangle.A media analysis shows that the coil was detached.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.With all the available information, boston scientific concludes that the reported event was confirmed.Based on the investigation results, it is most likely that the damage was caused by using excessive force or manipulation.The tangled noted on the cone prevented the cone from fully opening or closing.It is probable that when they were using the coil force and manipulation was exerted causing the wiring deformation and the sheath to be peeled from the coil.Additionally, the ifu states, if resistance is encountered while attempting to withdraw the coil do not exert excessive force.To release the object from the device, advance the sheath to straighten the coil and remove the device.Therefore, the most probable root cause is unintended use error caused or contributed to event.

Event Description

It was reported to boston scientific corporation that a nitinol retrieval coil was used during a ureteroscopy procedure performed on (b)(6) 2024.During the procedure, the stone cone was used to avoid migration of the stones; however, it was noticed that one portion of the cone was still inside the patient.It was reported that the piece was removed inside the patient using a dakota basket.The procedure was completed with another nitinol retrieval coil.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: 18735478
• MDR Text Key: 335699256
• Report Number: 2124215-2024-09308
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: 08714729430209
• Combination Product (y/n): N
• Reporter Country Code: CS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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 Expiration Date: 10/31/2019
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: G06111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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
• Patient Sex: Male