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

Model Number M0063903200

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 05/15/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: initial reporter address 1: (b)(6) block h6: device code a020504 captures the reportable event of a slit was found in the inner packaging of the device.

Event Description

It was reported to boston scientific corporation that a stone cone was used in the ureter during a ureter lithotomy performed on (b)(6) 2023.During preparation, a slit was found in the inner packaging of the device, and it was not tightly packed.Another stone cone was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a stone cone was used in the ureter during a ureter lithotomy performed on (b)(6) 2023.During preparation, a slit was found in the inner packaging of the device, and it was not tightly packed.Another stone cone was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block e1: initial reporter address 1 (b)(6).Block h6: device code a020504 captures the reportable event of a slit was found in the inner packaging of the device.Block h10: a stone cone was returned for inspection, and a visual analysis observed the device came with the handle, and the cone was received in an open state.The packaging of the device was not returned.Additional inspection found a tangle on the cone stopping it from fully closing, and the sheath was peeled.Functional testing found the cone can be partially closed.When trying to close the cone, it stopped at the area of the tangle.The packaging of the device was not received; therefore, the reported event was not confirmed.Based on all available information, it is most likely that the damage observed was caused by excessive force or manipulation.The tangle noted on the cone prevented the cone from fully closing.It is probable that force was exerted when they were testing the cone causing the wiring deformation and the sheath to become peeled.Additionally, the instructions for use (ifu) states "prior to use, ensure that the coil is working properly by advancing the sheath over the coil to the positive stop and then retracting the sheath to open the coil.The sheath of the device should be straight during testing." the investigation did not identify any abnormality in manufacturing or design.Therefore, the investigation conclusion code assigned 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) / product label.

• 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: 17037228
• MDR Text Key: 316705106
• Report Number: 3005099803-2023-02930
• 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
• Report Date: 08/10/2023

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: 04/19/2024
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0006372269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 55 KG