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

Model Number	M00550330
Medical Device Problem Codes	Burst Container or Vessel (1074); Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is: (b)(6).Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the lung during a balloon dilatation for a tracheal stenosis procedure performed on (b)(6) 2023.During preparation, when the physician unpacked the device, it was found to be kinked.The customer reported that the balloon burst when the device was brought from the hospital.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the lung during a balloon dilatation for a tracheal stenosis procedure performed on (b)(6) 2023.During preparation, when the physician unpacked the device, it was found to be kinked.The customer reported that the balloon burst when the device was brought from the hospital.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on december 19, 2023.Additional information was received that the balloon was pre-inflated, and the customer stated that no pieces of the balloon detached inside the patient when the balloon burst.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is: the first affiliated (b)(6) hospital.Block h2: additional information: block b5 (describe event or problem) and block h6 (use of device problem) block h6: imdrf device code a0402 captures the reportable event of a balloon burst.

• Brand Name: CRE PULMONARY
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18313501
• Report Number: 3005099803-2023-06640
• Device Sequence Number: 12422924
• Product Code: KTI
• UDI-Device Identifier: 08714729456216
• UDI-Public: 08714729456216
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2026
• Device Model Number: M00550330
• Device Catalogue Number: 5033
• Device Lot Number: 0031795856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 75 KG