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

Model Number M0063901050

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

Device code a0401 captures the reportable event of the basket wire break.Impact code f2301 captures the reportable event that the basket wire was retrieved with forceps.

Event Description

It was reported to boston scientific corporation that a zero tip basket was used in the left and right kidney during a stone removal procedure performed on (b)(6) 2023.During procedure, after lithotripsy, the basket was opened and prepared for removal of multiple kidney stones and calculi in the kidney.The device was in good condition prior to the procedure, but during use, the basket wire became unstable and bent.The physician continued with another cycle.On the third actuation, the basket broke at the tip.The basket wire completely detached from the basket and was retrieved with forceps within the scope.The procedure was completed with a non-bsc device.There were no patient complications as a result of this event.

Event Description

It was reported to boston scientific corporation that a zero tip basket was used in the left and right kidney during a stone removal procedure performed on (b)(6) 2023.During procedure, after lithotripsy, the basket was opened and prepared for removal of multiple kidney stones and calculi in the kidney.The device was in good condition prior to the procedure, but during use, the basket wire became unstable and bent.The physician continued with another cycle.On the third actuation, the basket broke at the tip.The basket wire completely detached from the basket and was retrieved with forceps within the scope.The procedure was completed with a non-bsc device.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: device code a0401 captures the reportable event of the basket wire break.Impact code f2301 captures the reportable event that the basket wire was retrieved with forceps.Block h10: the returned trapezoid rx basket was in a closed state and the sheath at the distal end of the basket may have been seen to be bent or kinked.The device was disassembled to inspect the basket, which was confirmed to be in good condition.During the dimensional examination, the site of measure "dim l.Assembled length" failed, causing the sheath to stretch out.For the functional inspection the handle was actuated, however basket was not able to open/close due to the sheath is stretch.The reported event was not confirmed.Based on all available information, is possible to conclude that some kind of force applied over the sheath caused the stretch observed, once the sheath got stretch the basket was left inside and could not come out, generating the actuation failure (open/close), moreover caused that the sheath got bent/kinked.Therefore, the most probable root cause is adverse event related to procedure.The basket was found not broken; therefore, it was concluded that the investigation conclusion code of this event will be documented as "no problem detected" since the device complaint or problem cannot be confirmed.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.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16362586
• MDR Text Key: 309387569
• Report Number: 3005099803-2023-00679
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: 08714729469643
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• 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: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• 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: 0029917929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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
• Patient Outcome(s): Required Intervention