MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAXFORCE TTS; DILATOR, ESOPHAGEAL

Model Number	M00589150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a maxforce tts dilatation balloon was used in the esophagus during an esophageal dilatation procedure performed on (b)(6) 2022.During the procedure, it was noted that the balloon ruptured.The procedure was completed with another maxforce tts dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2: block e1 has been updated based on additional information received september 11, 2022.Block h6: device code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce tts dilatation balloon was used in the esophagus during an esophageal dilatation procedure performed on august 24, 2022.During the procedure, it was noted that the balloon ruptured.The procedure was completed with another maxforce tts 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 maxforce tts dilatation balloon was used in the esophagus during an esophageal dilatation procedure performed on (b)(6) 2022.During the procedure, it was noted that the balloon ruptured.The procedure was completed with another maxforce tts dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0402 captures the reportable event of balloon burst.Block h10: investigation result: the returned maxforce tts balloon was analyzed and a visual examination found that the balloon has no visual defects and was in good condition.The 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 30mm from the proximal bond.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.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 revealed that no anomalies or deviations related to the event occurred during manufacturing.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: MAXFORCE TTS
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15412555
• Report Number: 3005099803-2022-05138
• Device Sequence Number: 5895107
• Product Code: KNQ
• UDI-Device Identifier: 08714729099918
• UDI-Public: 08714729099918
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K934697
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2022

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 Expiration Date: 02/04/2024
• Device Model Number: M00589150
• Device Catalogue Number: 8915
• Device Lot Number: 0028809174
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 09/11/2022; 10/10/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 09/30/2022; 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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