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

Model Number	M00567420
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, after the dilation was completed, deflation was attempted to be performed; however, the balloon could not be deflated.The procedure had already been completed successfully with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a140101 captures the reportable event of balloon failure to deflate.Block h10: investigation result: the returned maxforce biliary dilatation balloon was analyzed and a visual examination found that the catheter was accordioned in different sections and was returned with a knot.It was also noticed that the device was returned with a stuck guidewire that was not manufactured by boston scientific.The balloon was returned completely deflated.A functional inspection could not be performed due to the physical condition of the returned device.No other problems with the device were noted.It was reported that the balloon could not be deflated during the procedure but, this could not be confirmed as the physical condition of the returned device did not allow for functional testing.It is possible that factors encountered during the procedure, such as handling of the device or the technique used by the physician could have resulted in the damaged encountered in the catheter.It is possible that factors and/or conditions related to procedure during the use of the device could have affected its performance and its intended purpose, leading to the reported event.Since the investigation findings do not lead to a clear conclusion regarding the cause of the event, the most probable root cause of the balloon failing to deflate is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, after the dilation was completed, deflation was attempted to be performed; however, the balloon could not be deflated.The procedure had already been completed successfully with the original device.There were no patient complications reported as a result of this event.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15965961
• Report Number: 3005099803-2022-07269
• Device Sequence Number: 12156248
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: 06/13/2024
• Device Model Number: M00567420
• Device Catalogue Number: 6742
• Device Lot Number: 0027485971
• 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: 11/18/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/13/2023
• 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