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

Model Number	M00567340
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the common bile duct.A 3.00mm x 15mm nc emerge balloon catheter was advanced over the wire for dilatation.However, during the first inflation, a hole and leak was noted.A second 3.00mm x 15mm nc emerge balloon catheter was used for dilatation but the same problem was encountered.The procedure was completed with another of same device.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The anatomy location was located in the common bile duct.A 3.00mm x 15mm nc emerge was used for dilation.However, when the balloon was advanced over the wire and through the stricture during first inflation, a hole/leak was noted on the balloon.The dilation was not completed.A second 3.00mm x 15mm nc emerge was used for dilation but encountered the same problem.The procedure was completed with another of same device.There were no patient complications nor injuries reported.Additional information received on (b)(6) 2022.It was reported to boston scientific corporation that a maxforce biliary dilation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, it was noticed that upon the first inflation there was a hole/leak and they were not able to complete the dilation.The same issue occurred with the second maxforce biliary dilation balloon.The procedure was completed with another maxforce biliary dilation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h11: the initial report submitted on this event on (b)(6) 2021 was submitted in error, as the event does not represent an mdr-reportable scenario.

• 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 CORK LIMITED; cork business technology park; model farm road; cork MN ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13124395
• Report Number: 2134265-2021-16377
• Device Sequence Number: 14551164
• Product Code: FGE
• UDI-Device Identifier: 08714729846529
• UDI-Public: 08714729846529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022
• 2 Devices were Involved in the Event: 1 2

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: 06/24/2022
• Device Model Number: M00567340
• Device Catalogue Number: 6734
• Device Lot Number: 0025634739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 12/31/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• 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