MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PULMONARY; BRONCHOSCOPE ACCESSORY

Model Number	M00550350
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a cre pulmonary dilatation catheter was used in the left main bronchus during a transtracheal balloon dilation procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon could not be pressurized.Reportedly, the balloon was taken out of the patient and tested after re-pressurization, and noticed that the tip of the balloon was leaking.The procedure was completed with another cre pulmonary dilatation catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) block h6: medical device problem code a0504 captures the reportable event of balloon leak.Block h10: the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11: correction: block e1 (initial reporter first name).
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a cre pulmonary dilatation catheter was used in the left main bronchus during a transtracheal balloon dilation procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon could not be pressurized.Reportedly, the balloon was taken out of the patient and tested after re-pressurization, and noticed that the tip of the balloon was leaking.The procedure was completed with another cre pulmonary dilatation catheter.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a cre pulmonary dilatation catheter was used in the left main bronchus during a transtracheal balloon dilation procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon could not be pressurized.Reportedly, the balloon was taken out of the patient and tested after re-pressurization, and noticed that the tip of the balloon was leaking.The procedure was completed with another cre pulmonary dilatation catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: medical device problem code a0504 captures the reportable event of balloon leak.Block h10: investigation results a visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole in the shoulder portion of the distal section on the body of the balloon, which confirms the reported event of the balloon leaking.This failure is likely due to factors encountered during the procedure, such as the technique used by the physician and/or the interaction with the scope when the physician advanced the balloon could have caused that the balloon was leaking during the procedure.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instruction for use (ifu)/product label.

• Brand Name: CRE PULMONARY
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12315818
• Report Number: 3005099803-2021-04075
• Device Sequence Number: 19793091
• Product Code: KTI
• UDI-Device Identifier: 08714729456230
• UDI-Public: 08714729456230
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023337
• 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,Followup
• Report Date (Section B): 09/09/2021

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: 11/12/2023
• Device Model Number: M00550350
• Device Catalogue Number: 5035
• Device Lot Number: 0026349304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 08/13/2021; 08/16/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 08/16/2021; 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 76