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

Model Number	M00589180
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that maxforce tts dilatation balloon was used in the esophagus during an upper endoscope procedure performed on an unknown date.During procedure, it was noticed that the a hole in the balloon and could only fill half way.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
Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.Block h6: device code a041001 captures the reportable event of balloon pinhole.Block h10: investigation results: a visual and microscopic examination of the returned complaint device found that the balloon had a hole, which confirms the reported event.The sheath was noted to be bent.Functional analysis cannot be performed due to the hole in the balloon.It is most likely that procedural factors encountered during procedure could have affected the device performance and its integrity.Handling and manipulation of the device during procedure can lead to the sheath bent.Also, it is possible that an exceed of the pressure recommended during procedure or handling during preparation could affected the device performance.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
Kit was reported to boston scientific corporation that maxforce tts dilatation balloon was used in the esophagus during an upper endoscope procedure performed on an unknown date.During procedure, it was noticed that the a hole in the balloon and could only fill half way.The procedure was completed with another maxforce tts dilatation balloon.There were no patient complications reported as a result of this event.

• 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: 12885306
• Report Number: 3005099803-2021-05986
• Device Sequence Number: 4024438
• Product Code: KNQ
• UDI-Device Identifier: 08714729099925
• UDI-Public: 08714729099925
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: 08/25/2023
• Device Model Number: M00589180
• Device Catalogue Number: 8918
• Device Lot Number: 0027902496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• 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 Sex: Unknown