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

Model Number	M00567330
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
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 dilation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, an attempt was made to inflate the balloon; however, resistance was felt indicating the balloon was inflating and then the pressure gauge zeroed out.The balloon was pulled out and it was noticed that it popped causing the device to leak.The procedure was completed with another maxforce biliary dilation balloon.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 an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, an attempt was made to inflate the balloon; however, resistance was felt indicating the balloon was inflating and then the pressure gauge zeroed out.The balloon was pulled out and it was noticed that it popped causing the device to leak.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 h6: problem code a0402 captures the reportable event of balloon burst.Block h10: investigation results visual examination of the returned complaint device found the balloon did not show visual defects and was in a good condition.No damage found on the catheter of the device.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole over the ro marker on the body of the balloon.Microscopic inspection was done and found the balloon had a pinhole, which does not confirm the reported event of balloon burst.Based on the most relevant information of the complaint event description, device analysis, and the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It is possible that the factors encountered during the procedure, the technique used by the physician and/or the interaction with the scope could have caused that the balloon had a 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: 11372002
• Report Number: 3005099803-2021-00621
• Device Sequence Number: 11705645
• Product Code: FGE
• UDI-Device Identifier: 08714729097037
• UDI-Public: 08714729097037
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: 05/29/2022
• Device Model Number: M00567330
• Device Catalogue Number: 6733
• Device Lot Number: 0023874248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1