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

Model Number	M00567370
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(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
Note: this report pertains to one of two maxforce biliary balloons used in the same patient and procedure.It was reported to boston scientific corporation that two maxforce biliary dilation balloons were used during a biliary dilation procedure performed on an unknown date.According to the complainant, during preparation, both balloons would not inflate due to small holes.Reportedly, the devices were removed and the procedure was completed with another maxforce biliary dilation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
Note: this report pertains to one of two maxforce biliary balloons used in the same patient and procedure.It was reported to boston scientific corporation that two maxforce biliary dilation balloons were used during a biliary dilation procedure performed on an unknown date.According to the complainant, during preparation, both balloons would not inflate due to small holes.Reportedly, the devices were removed and the procedure was completed with another maxforce biliary dilation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block b3: date of event: date of event was approximated to (b)(6)2019 as no event date was reported.Block h6: problem code 1504 captures the reportable event of balloon pinhole.Block h10: investigation result a visual examination of the complaint device found that the device did not have any visual defects.The inner radio opaque (ro) markers inside the balloon were inspected for any sharp edge but none of them showed abnormalities.Functional analysis was performed and the balloon was inflated without problem; however, the balloon would not hold pressure due to a pinhole located at the body of the balloon material.This failure is likely due to factors or conditions related to procedure, such as the technique used by the physician during the procedure, the amount of strength applied by the customer during the movement of the device, the interaction between the scope and the balloon as well as the manner as the device was handled and manipulated which could have affected the device performance and its intended purpose.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.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

• 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: 9516281
• Report Number: 3005099803-2019-06192
• Device Sequence Number: 10872427
• Product Code: FGE
• UDI-Device Identifier: 08714729097068
• UDI-Public: 08714729097068
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K910931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: 09/10/2021
• Device Model Number: M00567370
• Device Catalogue Number: 6737
• Device Lot Number: 0022636695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1