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

Model Number	M00550320
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was being prepared to be used in the trachea during a balloon dilatation procedure performed on (b)(6) 2025.During preparation, when the package was opened, the front end of the catheter was found to be damaged.The procedure was completed with another cre pulmonary dilatation balloon.No further information has been obtained despite good faith efforts.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 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 e1: initial reporter's facility name is the second affiliated hospital of chongqing medical university; reported here as the facility name exceeded the character limit for the designated field.Block h6: imdrf device code a04 captures the reportable event of a balloon damage.
Additional Manufacturer Narrative
Block e1: initial reporter's facility name is (b)(6); reported here as the facility name exceeded the character limit for the designated field.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 a04 captures the reportable event of a balloon damage.Block h11: investigation results the returned cre pulmonary dilatation balloon was analyzed, and a visual and microscopic evaluation found no damages.Functional testing was performed, and the balloon was inflated without a problem and was able to hold pressure.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes that the reported event of balloon damaged/defective could not be confirmed.The returned device had no visual damages, was inflated without a problem, and was able to hold pressure.Therefore, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was being prepared to be used in the trachea during a balloon dilatation procedure performed on (b)(6) 2025.During preparation, when the package was opened, the front end of the catheter was found to be damaged.The procedure was completed with another cre pulmonary dilatation balloon.No further information has been obtained despite good faith efforts.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 e1: initial reporter's facility name is (b)(6); reported here as the facility name exceeded the character limit for the designated field.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 h2 (additional information): block e1 (initial reporter address and zip/post code) have been updated.Block h6: imdrf device code a04 captures the reportable event of a balloon damage.Block h11: investigation results- the returned cre pulmonary dilatation balloon was analyzed, and a visual and microscopic evaluation found no damages.Functional testing was performed, and the balloon was inflated without a problem and was able to hold pressure.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes that the reported event of balloon damaged/defective could not be confirmed.The returned device had no visual damages, was inflated without a problem, and was able to hold pressure.Therefore, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was being prepared to be used in the trachea during a balloon dilatation procedure performed on (b)(6) 2025.During preparation, when the package was opened, the front end of the catheter was found to be damaged.The procedure was completed with another cre pulmonary dilatation balloon.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.The patient's condition after 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21528670
• Report Number: 3005099803-2025-00669
• Device Sequence Number: 15548265
• Product Code: KTI
• UDI-Device Identifier: 08714729456209
• UDI-Public: (01)08714729456209(17)260312(10)31223271
• 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,Followup
• Report Date (Section B): 06/06/2025

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: 02/07/2025
• Supplement Date Received by Manufacturer: 03/19/2025; 05/21/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/10/2025; 06/07/2025
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 67 KG