MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAXFORCE; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00567420
Medical Device Problem Codes	Inflation Problem (1310); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary balloon was used in the papilla of vater during an endoscopic balloon dilation (ebd) procedure performed on (b)(6) 2021.During the procedure, the balloon was poorly pressurized while dilating the papilla.The procedure was completed with another maxforce balloon.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of balloon detached/separated.
Additional Manufacturer Narrative
(b)(4).The returned maxforce biliary balloon device was analyzed and a visual evaluation noted that the catheter was stretched and the balloon was not returned; it was detached.No other problems with the returned device were noted.The reported event of balloon failure to inflate could not be confirmed because the balloon was not returned for analysis.Additionally, it was observed that the catheter was returned stretched.It is possible that handling and manipulation of the device during the procedure could lead to stretching of the catheter.Also, it is possible that during removal of the device or after the procedure, the balloon could detach from the catheter.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.

• Brand Name: MAXFORCE
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13550093
• Report Number: 3005099803-2022-00784
• Device Sequence Number: 5269286
• Product Code: FGE
• UDI-Device Identifier: 08714729097099
• UDI-Public: 08714729097099
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910931
• 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
• Report Date (Section B): 02/17/2022

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: 06/13/2024
• Device Model Number: M00567420
• Device Catalogue Number: 6742
• Device Lot Number: 0027485970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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