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

Model Number	M00550320
Medical Device Problem Codes	Material Puncture/Hole (1504); Component Missing (2306); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of a balloon pinhole.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the trachea during a balloon catheter dilatation procedure performed on (b)(6) 2024.During the procedure, water leak was noticed during balloon dilation.It was reported that no pressure value indicator card was included.The procedure was completed with a different device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.Note: video of the complaint device outside the patient were provided by the customer and showed the water leaked thru a pinhole.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the trachea during a balloon catheter dilatation procedure performed on (b)(6) 2024.During the procedure, water leak was noticed during balloon dilation.The procedure was completed with a different device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.Note: video of the complaint device outside the patient were provided by the customer and showed the water leaked thru a pinhole.
Additional Manufacturer Narrative
Block g4: the remaining premarket/510(k) number is k170759; reported here as premarket/510(k) number exceeded the character limit for the designated field.Block h6: imdrf device code a041001 captures the reportable event of a balloon pinhole.Block h11: investigation results the returned cre pulmonary dilatation balloon was analyzed, and a visual inspection found no damage to the device.Functional and microscopic inspection found that the balloon had a pinhole approximately 83 mm from the device tip.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon pinhole was confirmed.The results of the analysis performed on the returned device found that the balloon had a pinhole approximately 83 mm from the device tip.The pinhole found is likely to have occurred due to procedural factors such as excess pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous the procedure could have caused the problem found on the distal section of the balloon.Based on all gathered information, the most probable root cause is an adverse event related to procedure.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21131342
• Report Number: 3005099803-2024-06815
• Device Sequence Number: 20728540
• Product Code: KTI
• UDI-Device Identifier: 08714729456209
• UDI-Public: 08714729456209
• 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): 03/07/2025

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: 03/12/2026
• Device Model Number: M00550320
• Device Catalogue Number: M00550320
• Device Lot Number: 0031223271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 65 KG