MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL

Model Number	M00558330
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophageal dilatation procedure performed on (b)(6) 2023.During the procedure, the balloon was found to be fractured after giving the pressure.The procedure was completed with another a cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Imdrf device code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophageal dilatation procedure performed on (b)(6) 2023.During the procedure, the balloon was found to be fractured after giving the pressure.The procedure was completed with another a cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Additional information received on may 21, 2023: the customer stated that the balloon burst and no pieces of the balloon detached inside the patient.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h10: investigation results the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the catheter of the device had no damages.Visual inspection of the balloon found it was ruptured.Functional analysis could not be performed due to the condition of the returned device.Microscopic inspection found a rupture located approximately at 72 mm from the tip.No other problems with the device were noted.With all the available information, boston scientific concludes that the reported event was confirmed.The rupture found in the balloon is likely to have occurred due to factors encountered during the procedure; it can be due to excess pressure, interaction with other devices, or anatomical affairs.These factors and interactions could influence the damage found in the balloon.However, it is possible that interaction with any surface during the procedure could create friction on the balloon, causing it to rupture during the procedure.Therefore, the most probable root cause is an 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 or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophageal dilatation procedure performed on (b)(6) 2023.During the procedure, the balloon was found to be fractured after giving the pressure.The procedure was completed with another a cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Additional information received on may 21, 2023: the customer stated that the balloon burst and no pieces of the balloon detached inside the patient.

• Brand Name: CRE FIXED WIRE
• Common Device Name: DILATOR, ESOPHAGEAL
• 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: 16970049
• Report Number: 3005099803-2023-02711
• Device Sequence Number: 17538039
• Product Code: KNQ
• UDI-Device Identifier: 08714729201984
• UDI-Public: 08714729201984
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2023
• Device Model Number: M00558330
• Device Catalogue Number: 5833
• Device Lot Number: 0027308605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 05/21/2023; 06/19/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/08/2023; 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 59 KG