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

Model Number	M00513210
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's age at the time of the event is reported to be (b)(6) yrs old.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 or Problem Description
It was reported to boston scientific corporation that a zero tip pulmonary basket was to be used in the trachea for a removal of tracheal foreign body procedure performed on (b)(6) 2021.During procedure, when the package was unpacked, the sheath of the zero tip device was found to be detached.The procedure was completed with another zero tip pulmonary basket.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.
Additional Manufacturer Narrative
Block a2: the patient's age at the time of the event is reported to be 2.5 yrs old.Block h6: medical device problem code a0501 captures the reportable event of sheath detached.Block h10: visual analysis of the returned zero tip pulmonary basket device found the sheath was torn at proximal section and was kinked/bent at distal section.The torn area was inspected under magnification and found evidence of torsion on the sheath.Based on all available information, it is most likely that handling and manipulation of the device during use can lead to the sheath kinking.Also, user technique to remove the device from its package can kink the sheath.The torn area observed on the sheath presented evidence of torsion that can result in tearing of the sheath during the use of the device.Therefore, the most probable root cause is adverse event related to procedure.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 or Problem Description
It was reported to boston scientific corporation that a zero tip pulmonary basket was to be used in the trachea for a removal of tracheal foreign body procedure performed on (b)(6) 2021.During procedure, when the package was unpacked, the sheath of the zero tip device was found to be detached.The procedure was completed with another zero tip pulmonary basket.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: ZERO TIP
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11837959
• Report Number: 3005099803-2021-02301
• Device Sequence Number: 4307843
• Product Code: KTI
• UDI-Device Identifier: 08714729415008
• UDI-Public: 08714729415008
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: M00513210
• Device Catalogue Number: 1321
• Device Lot Number: 0025952751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Received by Manufacturer: 04/25/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 15