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

Model Number	M00567380
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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) 2021.During the procedure, the device was advance over the guidewire; however, the device could not advance farther than 30 cm.Subsequently, the catheter bunched up in accordion and the guidewire could not be removed either.The device was then successfully removed from the scope using force which ripped off the balloon.The procedure was completed with another maxforce biliary dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of balloon detachment.Block h10: investigation results: a visual examination of the returned complaint device found that the catheter was buckled in a couple of sections and was stretched.An unknown guidewire was returned loaded and was stuck inside the device.The distal part of the device including the balloon was found detached from the rest of the device and was not returned, thereby confirming the reported event.Microscopic inspection was performed and confirmed the catheter was buckled and stretched, and the detachment of the distal section of the device.Dimensional examination was performed to the outer diameter (od) of the unknown guidewire and was measured in several locations.The guidewire meets the diameter specified within the instructions for use (ifu).It is most likely that procedural or anatomical factors encountered during the procedure, such as handling and manipulation of the device, the interaction between the device with the scope could have caused some friction to advance the guidewire.Continued attempts to advance the device and the guidewire can lead to buckle on the catheter, and once the catheter is buckled, the guidewire can get caught inside the device making it unable to be removed.Additionally, the buckled on the catheter can cause difficulty to remove the device from the scope, which leads to the used of force to pull the balloon out of the endoscope.This force applied to the device can cause the catheter to stretch until it breaks, leading to the reported problem of balloon detachment.Therefore, the most probable root cause is adverse event related to procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
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), 2021.During the procedure, the device was advance over the guidewire; however, the device could not advance farther than 30 cm.Subsequently, the catheter bunched up in accordion and the guidewire could not be removed either.The device was then successfully removed from the scope using force which ripped off the balloon.The procedure was completed with another maxforce biliary dilatation balloon.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
• MDR Report Key: 12125866
• Report Number: 3005099803-2021-03203
• Device Sequence Number: 19918900
• Product Code: FGE
• UDI-Device Identifier: 08714729097075
• UDI-Public: 08714729097075
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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: 11/04/2023
• Device Model Number: M00567380
• Device Catalogue Number: 6738
• Device Lot Number: 0026300309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1