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

Model Number	M00550330
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a cre pulmonary dilatation catheter was used in the larynx during a procedure performed on (b)(6) 2021.The narrow airway tree was dilated by endoscope, and the positioning of the balloon at the narrow point provided a visual reference point.It was reported that when the larynx was dilated by the balloon during treatment, the balloon leaked after the first dilatation.An alliance syringe was then used to deflate the balloon; however, a sound was heard from the syringe which frightened and caused anxiety to the (b)(6) month-old patient.The procedure was completed with another cre pulmonary device.In the physician's assessment, there was no serious injury, and no treatment was needed for the patient effects.The patient's current condition was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a cre pulmonary dilatation catheter was used in the larynx during a procedure performed on (b)(6) 2021.The narrow airway tree was dilated by endoscope, and the positioning of the balloon at the narrow point provided a visual reference point.It was reported that when the larynx was dilated by the balloon during treatment, the balloon leaked after the first dilatation.An alliance syringe was then used to deflate the balloon; however, a sound was heard from the syringe which frightened and caused anxiety to the 5-month-old patient.The procedure was completed with another cre pulmonary device.In the physician's assessment, there was no serious injury, and no treatment was needed for the patient effects.The patient's current condition was reported to be stable.Correction: note: the instructions for use (ifu) indicate that the cre pulmonary is intended to endoscopically dilate strictures of the airway tree; however, the balloon was used to dilate the larynx for this case.Additional information received on march 14, 2021: it was clarified that the sound heard was from the alliance handle, not from the alliance syringe.Additionally the procedure was completed with this inflation device.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: device code a0504 captures the reportable event of balloon leak.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

• Brand Name: CRE PULMONARY
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11419016
• Report Number: 3005099803-2021-00816
• Device Sequence Number: 2775611
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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: 07/14/2022
• Device Model Number: M00550330
• Device Catalogue Number: 5033
• Device Lot Number: 0024104733
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 MO