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

Model Number	M00550350
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was attempted to be used in the bronchus during a bronchoscopy procedure performed on an unknown date.During the procedure, the balloon leaked water and could not hold pressure.A video clip was provided showing the balloon leaked through a pinhole.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 after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not used past its expiry date.Block h6: imdrf device code a041001 captures the reportable event of a balloon pinhole in the bronchus.

• 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: 20888803
• Report Number: 3005099803-2024-06166
• Device Sequence Number: 20794214
• Product Code: KTI
• UDI-Device Identifier: 08714729456230
• UDI-Public: 08714729456230
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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 Model Number: M00550350
• Device Catalogue Number: M00550350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/10/2024
• 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: 61 YR
• Patient Sex: Female