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

Model Number M0063903200

Device Problems Peeled/Delaminated (1454); Difficult to Open or Close (2921)

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

Event Date 09/07/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2021.During the procedure, the stone cone was unable to form a coil.The procedure was completed with another stone cone device.There were no patient complications reported as a result of this event.The investigation results revealed the coil/cone peeled/sheared; therefore, this is now an mdr reportable event.

Manufacturer Narrative

(b)(4).Visual analysis of the returned device found that peeling was noted on the coating of the coil.System was not able to be closed beyond that point.Therefore, the reported event of coil failed to open is not confirmed.Based on all available information, it is likely that the user experienced difficulty while testing the device prior to use.The instructions for use (ifu) warns the user, 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.Therefore, the most probable root cause is unintended use error caused or contributed to event.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / 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: 12955014
• MDR Text Key: 285338650
• Report Number: 3005099803-2021-06972
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2021

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: 08/21/2023
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0005934757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2020
• 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