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

Model Number	M00545690
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2021.During the procedure, when the physician attempted to deploy the stent, it was noticed that the stent broke in two pieces in the bile duct.The broken pieces of stent were retrieved with the use of snare and another flexima rx biliary stent successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of stent break.Block h10: the returned flexima rx biliary stent was analyzed, and a visual evaluation noted that the guide catheter was detached, kinked and stretched.The push catheter was kinked.The stent was not returned for analysis.No other issues were noted.The reported event was not confirmed.According to the product analysis, based on the information provided and the analysis results, it is possible that due to the manipulation or technique used at the time of interacting with the device, along with the patient's tortuosity or anatomical conditions may have trapped the stent, affecting the functionality to be deployed causing the break.The conditions of the guide catheter, kink, detached and stretched along with the kinked push catheter suggests than an excess of tension and force was applied.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.The reported stent break could not be confirmed due to the stent did not return to perform the analysis, and was assigned as.No problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2021.During the procedure, when the physician attempted to deploy the stent, it was noticed that the stent broke in two pieces in the bile duct.The broken pieces of stent were retrieved with the use of snare and another flexima rx biliary stent successfully completed the procedure.There were no patient complications reported as a result of this event.

• Brand Name: RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12119961
• Report Number: 3005099803-2021-03109
• Device Sequence Number: 17318551
• Product Code: FGE
• UDI-Device Identifier: 08714729301868
• UDI-Public: 08714729301868
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K965147
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: M00545690
• Device Catalogue Number: 4569
• Device Lot Number: 0026106649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown