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

Model Number M00550350

Device Problems Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: the initial reporter facility name: (b)(6) hospital.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 main airway during an airway stenosis and recanalization procedure performed on june 26, 2023.During the procedure, the balloon burst when it was inflated to 13.5 mm.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.

Event Description

It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the main airway during an airway stenosis and recanalization procedure performed on (b)(6) 2023.During the procedure, the balloon burst when it was inflated to 13.5 mm.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: second affiliated (b)(6).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 was ruptured and there is evidence of a mechanical cut inside the detached balloon.The catheter of the device was carefully inspected, and no damages were found.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was confirmed.The results of the analysis performed on the returned device showed that the balloon was burst.In addition, the balloon was detached, and it has evidence of a mechanical cut inside.It is possible that the rupture of the balloon occurred due to procedural factors such as excess of pressure, interaction with other devices like a sharp surface during or previous the procedure, or even the patient's anatomical conditions could have caused the problem found on the distal section of the balloon.After the problem, it may have been necessary to separate the broken balloon using a cutting tool, which would explain the type of cut found.Therefore, the most probable root cause is an adverse event related to procedure.

• 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: 18144275
• MDR Text Key: 328372584
• Report Number: 3005099803-2023-06154
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 08714729456230
• UDI-Public: 08714729456230
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00550350
• Device Catalogue Number: 5035
• Device Lot Number: 0030171980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2022
• 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: 35 YR
• Patient Sex: Male
• Patient Weight: 55 KG