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

Model Number	M00567420
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and 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 dilation balloon was used in the bile duct during a biliary tract dilation procedure performed on an unknown date.According to the complainant, during the procedure, it was noticed that the balloon was leaking near the balloon proximal side when inflated in the papilla of the patient, and it was determined that the balloon ruptured.Reportedly, the balloon was tested prior to the procedure without problem.The procedure was completed at this time.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilation balloon was used in the bile duct during a biliary tract dilation procedure performed on an unknown date.According to the complainant, during the procedure, it was noticed that the balloon was leaking near the balloon proximal side when inflated in the papilla of the patient, and it was determined that the balloon ruptured.Reportedly, the balloon was tested prior to the procedure without problem.The procedure was completed at this time.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6)2020 as no event date was reported.Block e1: initial reporter city: (b)(6) block h6: device code a0402 captures the reportable event of balloon burst.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 was performed and a balloon pinhole was found; therefore the reported issue of balloon burst was not confirmed.Functional evaluation was performed by attaching the device into an alliance inflation system, the balloon was inflated without problem; however, it was noted that there was a pinhole in the proximal section of the balloon.Based on the available information, it is possible that factors encountered during the procedure, such as the technique used by the physician and/or interaction with the scope, could have caused the pinhole during the procedure.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.

• 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: 11111871
• Report Number: 3005099803-2020-06546
• Device Sequence Number: 3609500
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 08/06/2022
• Device Model Number: M00567420
• Device Catalogue Number: 6742
• Device Lot Number: 0024227406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1