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

Model Number	M00567420
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 distal bile duct during an endoscopic papillary balloon dilation (epbd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon did not inflate when attempted to be inflated.The balloon was checked and showed that the balloon had a pinhole.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 e1: initial reporter facility name: (b)(6).Initial reporter city: (b)(6).Block h6: device code 1504 captures the reportable event of balloon pinhole.Block h10: investigation result: a visual examination of the returned complaint device found that the balloon did not have any visual defects and was in a good condition.No damage was found on the catheter of the device.A microscopic examination of the balloon found a pinhole in the proximal section of the body of the balloon.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole in the proximal section of the body of the balloon.This failure is likely due to factors or conditions related to the procedure during the use of the device, such as patient anatomy, and/or the interaction with the scope, that could have caused the balloon pinhole and, for that reason, did not hold the pressure.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 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 distal bile duct during an endoscopic papillary balloon dilation (epbd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon did not inflate when attempted to be inflated.The balloon was checked and showed that the balloon had a pinhole.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: 10666797
• Report Number: 3005099803-2020-04451
• Device Sequence Number: 3903321
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: 06/27/2022
• Device Model Number: M00567420
• Device Catalogue Number: 6742
• Device Lot Number: 0024029736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1