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

Model Number	M00558350
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).
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 performed on (b)(6) 2022.During the procedure, balloon inflation was attempted however, it could not be inflated.The device was removed from the patient and it was noticed that the balloon had ruptured.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.
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 performed on (b)(6) 2022.During the procedure, balloon inflation was attempted however, it could not be inflated.The device was removed from the patient and it was noticed that the balloon had ruptured.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: device code a0402 captures the reportable event of balloon burst.Block h10: investigation result: the returned cre fixed wire dilatation balloon 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 a pinhole in the distal section of the balloon.Microscopic inspection found the balloon had a pinhole located approximately 98mm from the tip.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 pinhole problem found could have been interpreted by the customer as the reported event of balloon burst.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 a pinhole.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lot numbers, and a manufacturing review of the most probable lot numbers did not identify any anomalies or deviations that could have contributed to the event.

• 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: 15794094
• Report Number: 3005099803-2022-06623
• Device Sequence Number: 4791264
• Product Code: KNQ
• UDI-Device Identifier: 08714729202004
• UDI-Public: 08714729202004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/12/2022

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 Model Number: M00558350
• Device Catalogue Number: 5835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown