MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP; BRONCHOSCOPE ACCESSORY

Model Number M00513210

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

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

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a0401 is being used to capture the reportable event of handle break.

Event Description

It was reported to boston scientific corporation that a zero tip pulmonary basket was to be used in the common bile duct during an endoscopic bile duct stone crushing during procedure performed on october 23, 2023.During unpacking, the handle was broken.Another zero tip pulmonary basket was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

Manufacturer Narrative

Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a0401 is being used to capture the reportable event of handle break.Block h10: the returned zero tip pulmonary basket was analyzed, and a visual inspection observed that the sheath was kinked in different sections, buckled and detached.No other issues were noted.The reported event that the handle was broken was not confirmed.Based on all available information, it is most likely that user manipulation, some technique applied during the procedure, and/or even anatomical factors contributed to the sheath detachment.Once the sheath was detached, the user may have experienced difficulties in manipulating the device, and this could have been perceived by the physician as handle break.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed, and from the information available, this device was used in accordance with the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a zero tip pulmonary basket was to be used in the common bile duct during an endoscopic bile duct stone crushing during procedure performed on (b)(6) 2023.During unpacking, the handle was broken.Another zero tip pulmonary basket was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• Brand Name: ZERO TIP
• Type of Device: BRONCHOSCOPE ACCESSORY
• 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: 18232446
• MDR Text Key: 329338703
• Report Number: 3005099803-2023-06431
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 08714729415008
• UDI-Public: 08714729415008
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K020765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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 Model Number: M00513210
• Device Catalogue Number: 1321
• Device Lot Number: 0029319502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2022
• 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 Age: 8 YR
• Patient Sex: Male
• Patient Weight: 44 KG