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

Model Number M00550310

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)

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

Event Date 07/18/2022

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices that were used in the same patient and procedure.It was reported to boston scientific corporation that two cre pulmonary dilatation balloons were used during a procedure performed on (b)(6) 2022.It was reported that balloon would not inflate.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.This event has been deemed a reportable event based on the investigation finding of balloon pinhole.

Manufacturer Narrative

Imdrf device code a041001 captures the reportable investigation result of balloon pinhole.Investigation results the returned cre pulmonary dilatation balloons was analyzed, and a visual examination found that the balloon and catheter of the device had no damages.Functional analysis was performed, and the balloon was inflated without a problem.However, the balloon would not hold pressure due to pinhole in the distal section of the balloon.Microscopic inspection found had a pinhole located approximately at 29 mm from the tip.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon would not inflate was confirmed.The pinhole found in the balloon is likely to have occurred due to factors encountered during the procedure: excess pressure, interaction with other devices, or patient anatomy.It is possible that factors encountered during the procedure, such as the interaction with any surface during the procedure could create friction on the balloon and cause to failure to inflate.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16381066
• MDR Text Key: 309604009
• Report Number: 3005099803-2023-00682
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 08714729456193
• UDI-Public: 08714729456193
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• 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: 0028630499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1