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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a stone cone was used in the ureter during a transurethral ureteroscopy ureteral pneumatic ballistic lithotripsy procedure performed on (b)(6) 2023.During preparation, the stone cone device was unpacked and when manipulated, the basket was broken upon pulling.Another stone cone was used to complete the procedure.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 stable.

Manufacturer Narrative

H6: imdrf device code a040506 captures the reportable event of coil peeled.

Event Description

It was reported to boston scientific corporation that a stone cone was used in the ureter during a transurethral ureteroscopy ureteral pneumatic ballistic lithotripsy procedure performed on (b)(6) 2023.During preparation, the stone cone device was unpacked and when manipulated, the basket was broken upon pulling.Another stone cone was used to complete the procedure.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 stable.***additional information received on august 10, 2023*** the disc sealing part at the tip of the device was broken.The surface of the coil (green/blue ptfe heat shrink) was completely damaged and detached, exposing the metal structure inside.

Manufacturer Narrative

Block b5 and block h6 (device codes) have been updated based on additional information received on august 10, 2023.Block h6: imdrf device code a0501 captures the reportable event of coil detached.

Event Description

It was reported to boston scientific corporation that a stone cone was used in the ureter during a transurethral ureteroscopy ureteral pneumatic ballistic lithotripsy procedure performed on (b)(6) 2023.During preparation, the stone cone device was unpacked and when manipulated, the basket was broken upon pulling.Another stone cone was used to complete the procedure.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 stable.Additional information received on august 10, 2023.The disc sealing part at the tip of the device was broken.The surface of the coil (green/blue ptfe heat shrink) was completely damaged and detached, exposing the metal structure inside.

Manufacturer Narrative

Block b5 and block h6 (device codes) have been updated based on additional information received on august 10, 2023.Block h6: imdrf device code a0501 captures the reportable event of coil detached.Block h10: the returned stone cone was analyzed, and a visual inspection observed the coil was received in an open state.There was a tangle on the coil.The sheath around the area was found peeled.Functional testing found the coil can be partially closed.When trying to close the coil, it stopped at the area of the tangle.The reported event was confirmed.Based on all available information, it is most likely that the damaged was caused by using excessive manipulation.The tangle in the cone prevented the cone from fully closing.It is probable that when the device was being tested, force was exerted, causing the wiring deformation and the coil sheath to peel and break off the coil body.Additionally, the instruction of use (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 investigation conclusion code is unintended use error, indicating that interaction between the user and the device caused or contributed to the error.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu) / labeling.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17545772
• MDR Text Key: 321115445
• Report Number: 3005099803-2023-04335
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 10/05/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2024
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0006390630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/10/2023; 09/14/2023
• Supplement Dates FDA Received: 08/31/2023; 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2021
• 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 Age: 38 YR
• Patient Sex: Male
• Patient Weight: 70 KG