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 09/02/2019

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 kidney during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the coil of the stone cone was difficult to close and remove from the patient.When the stone cone was taken out, the coil was found broken with the distal part left inside the patient.Biopsy forceps was used to retrieve the detached coil and the procedure was completed.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: device code 2907 captures the reported event of coil was detached/separated.Block h10: visual analysis found the device was received fragmented into three sections.The first section, which is the sheath, is detached from the device.There was no clear damage to sheath.The second section, which is the tip of the device, was detached from the tip of the coil to the ball weld.There were what appeared to be scorching on the blue green coating and darkening of the core wire where it was broken.The remaining section received includes the white heat shrink, nitinol core wire, and remainder of the broken coil.Due to the damaged condition of the device, a functional assessment was unable to be performed.Based on all available information, it is likely that the device was damaged by the laser during lithotripsy.Product analysis found that there appeared to be scorching on the blue green coating and darkening of the core wire where it was broken.A labeling review was performed and from the information available, this device was not used per the directions for use (dfu)/product label as it is likely that during laser use, the device was damaged by the laser during lithotripsy.The directions for use (dfu) states "do not directly fire upon the device with a laser." therefore, the most probable root cause is failure to follow instructions, which indicates that the 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.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the kidney during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the coil of the stone cone was difficult to close and remove from the patient.When the stone cone was taken out, the coil was found broken with the distal part left inside the patient.Biopsy forceps was used to retrieve the detached coil and the procedure was completed.There were no patient complications as a result of this event.

• 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: 9116969
• MDR Text Key: 161679844
• Report Number: 3005099803-2019-04734
• 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: 11/18/2019

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: 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: 10/10/2019
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention