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

Model Number M0063903200

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was to be used in the ureter on a kidney stone holmium laser lithotripsy performed on (b)(6), 2019.According to the complainant, during unpacking, the coil was found detached from the device.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.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was to be used in the ureter on a kidney stone holmium laser lithotripsy performed on (b)(6) 2019.According to the complainant, during unpacking, the coil was found detached from the device.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

Block h6: device code 2907 captures the reportable event of coil detached.Block h10: visual inspection of the returned device found the blue outer sheath was extended past the distal tip.The sheath was not able to be moved and the coil could not be unsheathed.The leading tip of the device was present and intact.No breaks were observed.The reported complaint of fractured coil is not confirmed.The instructions for use (ifu) indicates not to exert excessive force when resistance is encountered when attempting to withdraw the coil.Based on all available information, it is most likely that while testing the device before use, excessive force on the outer sheath caused it to extend past the distal stop, and the coil was not able to open.Therefore, the most probable root cause is failure to follow instructions, indicating problems traced to the user not following the manufacturer's instructions.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.

• Brand Name: STONE CONE
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10186844
• MDR Text Key: 197139317
• Report Number: 3005099803-2020-02349
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

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: 12/06/2020
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0004023644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 78