MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number M0063901050

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code code a0401 captures the reportable event of basket wire broke off.Imdrf patient code code e2008 captures the reportable event unretrieved device fragment.

Event Description

It was reported to boston scientific corporation that a zero tip basket was used in the kidney during a cystoscopy ureteroscopy stent procedure performed on (b)(6) 2023.During the procedure, the part of the basket broke off and became loose while inside the patent.It was also reported that the patient had passed away.However, it was stated that the death of the patient was not related to the procedure.

Manufacturer Narrative

Block h6: imdrf device code code a0401 captures the reportable event of basket wire broke off.Imdrf patient code code e2008 captures the reportable event unretrieved device fragment.H2: correction block b5 (describe event or problem) has been updated based on the correct procedure date of (b)(6) 2023 block h10: investigation results the returned zero tip basket was analyzed, and a visual evaluation noted that the sheath was detached at the proximal section and buckled/accordioned in different parts.It was also noted that the sheath was kinked at the distal section.Functional examination was not possible to perform due to detachment.An x-ray was performed, and it was found that the basket was fully detached from the device.Additionally, the device was disassembled and there is no evidence that the device was assembled incorrectly.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu).With all the available information, boston scientific concludes that the reported event of basket wire break was not confirmed, since the basket was fully detached from the device, and it was not return.Based on the investigation results the excess of force applied to the device probably when trying to remove the stone could have damaged the basket.The buckles and kinks encountered indicate that the device was submitted to tension or resistance during the procedure, once resistance was in the device, and excess force applied, the basket could have detached, affecting the performance of the device.The inspection states, inspect that basket wires and mandrel are visible in notch using vision system.In the case they are not visible, then scrap.Additionally, there is a confirmation step that states: confirm 8 crimp indenter marks on both sides of notch using vision system and in the case they are not visible, then scrap.These inspections ensure the assembly of the basket on the device.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.

Event Description

It was reported to boston scientific corporation that a zero tip basket was used in the kidney during a cystoscopy ureteroscopy stent procedure performed on (b)(6) 2023.During the procedure, the part of the basket broke off and became loose while inside the patent.It was also reported that the patient had passed away.However, it was stated that the death of the patient was not related to the procedure.

• Brand Name: ZERO TIP
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18325790
• MDR Text Key: 330492471
• Report Number: 2124215-2023-69582
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 0032128968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other