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

Model Number M00550340

Device Problems Burst Container or Vessel (1074); Component Missing (2306)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the left principal bronchus during a balloon dilatation procedure performed on (b)(6) 2023.Upon unpacking of the device, it was noticed that the balloon pressure label was missing.During the procedure, the balloon burst.The customer stated that no pieces of the balloon detached inside the patient.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 at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1: the initial reporter facility name is: (b)(6).Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.

Event Description

It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the left principal bronchus during a balloon dilatation procedure performed on (b)(6) 2023.Upon unpacking of the device, it was noticed that the balloon pressure label was missing.During the procedure, the balloon burst.The customer stated that no pieces of the balloon detached inside the patient.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 at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1: the initial reporter facility name is: block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h10: investigation results: the returned cre pulmonary dilatation balloon was analyzed, and a visual examination found that the balloon and catheter of the device had no damages.The device was not returned with the pressure label.Functional analysis was performed, and the balloon was inflated without a problem, and it was able to hold the pressure.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The results of the returned device analysis indicated that the balloon could be inflated and had no problem holding pressure.The balloon was returned in good condition, and there was no evidence of damage that could be associated with the reported event.Perhaps the technique used, or patient's anatomical conditions could have contributed to the customer interpreting the event as a balloon burst, however, there is not enough objective evidence to determine that it occurred due to a device problem.Therefore, the most probable root cause is no problem detected.

• 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: 18269378
• MDR Text Key: 329749865
• Report Number: 3005099803-2023-06428
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 08714729456223
• UDI-Public: 08714729456223
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00550340
• Device Catalogue Number: 5034
• Device Lot Number: 0030268026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 56 KG