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

Model Number M00550310

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the subglottic during an endoscopic dilatation of trachea procedure performed on november 3, 2023.During the procedure, the balloon was leaking saline into the patient's lungs.The balloon was then inspected, and a small hole was noted.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a041001 captures the reportable event of a balloon pinhole.

• Brand Name: CRE PULMONARY
• Type of Device: 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: 18185532
• MDR Text Key: 328706165
• Report Number: 3005099803-2023-06323
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 08714729456193
• UDI-Public: 08714729456193
• Combination Product (y/n): N
• Reporter Country Code: IC
• PMA/PMN Number: K023337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00550310
• Device Catalogue Number: 5031
• Device Lot Number: 0032120529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female