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

Model Number	M00550330
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0410 captures the reportable event of balloon hole.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloons was used in the bronchus during an intratracheal stent placement procedure performed on (b)(6) 2023.During the procedure, it was noticed that the balloon was leaking liquid after pressure was applied and it could not hold enough pressure to maintain support.It was also noted that there was a hole.The procedure was completed with another cre pulmonary dilatation balloons.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0410 captures the reportable event of balloon hole.Block h10: investigation results: the returned cre pulmonary dilatation balloon was analyzed, and a visual and microscopic examination found the balloon was burst.No damages were found on the catheter of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event balloon pinhole cannot be confirmed.The burst problem found could have been interpreted by the customer as the reported event of a balloon pinhole.It is possible that the pinhole found in the balloon occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during/previous the procedure could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloons was used in the bronchus during an intratracheal stent placement procedure performed on (b)(6) 2023.During the procedure, it was noticed that the balloon was leaking liquid after pressure was applied and it could not hold enough pressure to maintain support.It was also noted that there was a hole.The procedure was completed with another cre pulmonary dilatation balloons.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17140758
• Report Number: 3005099803-2023-03180
• Device Sequence Number: 20755667
• 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): 08/17/2023

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: 08/29/2024
• Device Model Number: M00550330
• Device Catalogue Number: 5033
• Device Lot Number: 0027928762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 54 KG