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 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual analysis of the returned device found the coil was partially exposed and tangled.Therefore, the reported event of coil failed to close is confirmed since the tangled coil would cause difficulty moving the outer sheath.The device was able to be untangled and sheathed fully.Some peeling was noted on the coating of the coil, and the tip of the blue outer sheath appeared stretched.The damage is consistent with force applied while attempting to sheath the coil.Additionally, scorching was noted on the sheath which is consistent with laser damage.Based on all available information, it is likely that the user experienced difficulty during the procedure due to the coil tangled.The damage is consistent with force applied while attempting to sheath the coil.Additionally, there is evidence of laser damage on the sheath.The instructions for use (ifu) warns the user, 'do not fire upon the device with a laser.' therefore, the most probable root cause is unintended use error caused or contributed to event.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.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 used in the ureter during a lithotripsy procedure performed on (b)(6) 2021.During the procedure, the coil was unable to straighten inside the patient.The procedure was completed with another stone cone device.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.The investigation results revealed the coil/cone peeled/sheared; therefore, this is now an mdr reportable 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11855632
• MDR Text Key: 251736321
• Report Number: 3005099803-2021-02247
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2022
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0004873027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2019
• 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