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

Model Number M0063903200

Device Problem Difficult to Open or Close (2921)

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

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

The returned stone cone was analyzed, and a visual evaluation found the coil exposed and tangled.The green coating of the coil was damaged such that the inner coil wire is exposed.Additionally, the outer blue sheath had a slight tear at the distal end.Due to the defects, functional testing found the coil could not be successfully opened or closed.Therefore, the reported event is confirmed.Based on all available information, it is highly unlikely that the defects described were present upon opening of the packaging.It is most likely that they were caused using excessive force or manipulation during testing.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 review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was to be used in the ureteral calculus ureteroscopic holmium laser lithotripsy procedure performed on (b)(6) 2021.During preparation, the stone cone was tested and found the device failed to form a coil.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.Note: this event has been deemed an mdr-reportable event based on the investigation results that the green coating of the coil was damaged and inner coil wire is exposed, and outer blue sheath had a slight tear at the distal end.

• 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: 13110355
• MDR Text Key: 284717501
• Report Number: 3005099803-2021-07928
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2023
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0005661511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG