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

Model Number M00550310

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 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0402 captures the reportable event of balloon burst.

Event Description

It was reported to boston scientific corporation that a cre pulmonary balloon was used in the trachea during a trachea balloon dilation procedure performed on (b)(6) 2023.During the procedure when the physician dilated the stenosis of trachea, the surface of the balloon was broken, resulting in liquid being sprayed.The procedure was completed with another cre pulmonary 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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a cre pulmonary balloon was used in the trachea during a trachea balloon dilation procedure performed on (b)(6) 2023.During the procedure when the physician dilated the stenosis of trachea, the surface of the balloon was broken, resulting in liquid being sprayed.The procedure was completed with another cre pulmonary 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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received on april 20, 2023, it was reported that the balloon burst at 3 atm.The customer stated that no pieces of the balloon detached inside the patient.

Manufacturer Narrative

Block h2: additional information: a1 (patient identifier), a2 (date of birth) and b5 (describe event or problem).Block h6: imdrf device code a0402 captures the reportable event of balloon burst.

Manufacturer Narrative

Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h2: correction in block b5: additional information was missed in previous report.Investigation results: the returned cre pulmonary balloon was analyzed and a visual and microscopic examination found the balloon was torn longitudinally.No damages were found on the catheter of the device.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of the balloon burst was not confirmed.The longitudinal tear found could have been interpreted by the customer as the reported event of a balloon burst.The balloon was found to be torn longitudinally, likely due to factors encountered during the procedure, such as excess pressure, the interaction with other devices, or anatomical affairs.However, it is possible that interaction with any surface during the procedure could have created friction, causing the balloon to be torn longitudinally.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 instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a cre pulmonary balloon was used in the trachea during a trachea balloon dilation procedure performed on (b)(6) 2023.During the procedure when the physician dilated the stenosis of trachea, the surface of the balloon was broken, resulting in liquid being sprayed.The procedure was completed with another cre pulmonary 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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.***additional information received on april 20, 2023*** it was reported that the balloon burst at 3 atm.The customer stated that no pieces of the balloon detached inside the patient.

Manufacturer Narrative

Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Investigation results: the returned cre pulmonary balloon was analyzed and a visual and microscopic examination found the balloon was torn longitudinally.No damages were found on the catheter of the device.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of the balloon burst was not confirmed.The longitudinal tear found could have been interpreted by the customer as the reported event of a balloon burst.The balloon was found to be torn longitudinally, likely due to factors encountered during the procedure, such as excess pressure, the interaction with other devices, or anatomical affairs.However, it is possible that interaction with any surface during the procedure could have created friction, causing the balloon to be torn longitudinally.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 instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a cre pulmonary balloon was used in the trachea during a trachea balloon dilation procedure performed on (b)(6) 2023.During the procedure when the physician dilated the stenosis of trachea, the surface of the balloon was broken, resulting in liquid being sprayed.The procedure was completed with another cre pulmonary 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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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 CORPORATION; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16753496
• MDR Text Key: 313442051
• Report Number: 3005099803-2023-01846
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 08714729456193
• UDI-Public: 08714729456193
• 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,Followup,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• 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: 0029002752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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: 28 YR
• Patient Sex: Female
• Patient Weight: 64 KG