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 10/04/2019

Event Type  Injury  

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 used in the ureter during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, resistance was noted when attempting to retract the coil.When the stone cone device was removed from the body, the coil was found detached.Fluoroscopy was performed and confirmed that the coil detached into the ureter.Under ureteroscope, a basket was used to remove the detached coil and the procedure was completed.Reportedly, a laser was used at the time the stone cone device was used.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 tip was detached from the middle of the coil to the ball weld.A discoloration was noted at the break and at the proximal side of the coil.Based on all available information, it is likely that device was damaged by the laser during lithotripsy as product analysis found that there appeared to be scorching on the blue green coating and darkening of the core wire where it was broken.The directions for use (dfu) states "do not directly fire upon the device with a laser." therefore, the most probable root cause is unintended user error caused or contributed to event since the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.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 directions for use (dfu)/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 transurethral lithotripsy (tul) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, resistance was noted when attempting to retract the coil.When the stone cone device was removed from the body, the coil was found detached.Fluoroscopy was performed and confirmed that the coil detached into the ureter.Under ureteroscope, a basket was used to remove the detached coil and the procedure was completed.Reportedly, a laser was used at the time the stone cone device was used.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.

• 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: 9279635
• MDR Text Key: 165087541
• Report Number: 3005099803-2019-05371
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0004910889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention