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

Model Number	M00545650
Medical Device Problem Codes	Break (1069); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 medwatch 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 common bile duct, performed on (b)(6) 2022.During the procedure, when the nurse attempted to deploy the stent and pulled back the guide catheter, the stent deployed prematurely and the guide catheter broke.The physician retrieved both the stent and guide catheter at the same time using a snare and decided not to place another stent to adequate the bile drainage.All broken pieces were removed from the patient and successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a0401 captures the reportable event of guide catheter break.Impact code f23 captures the reportable event of unexpected medical intervention.Block h10: the returned flexima rx biliary stent was analyzed, and a visual evaluation noted that the push catheter was kinked at distal end.The guide catheter was detached from the delivery system, it was visually inspected and it was kinked in some locations.If the guide catheter detaches from the delivery system, the stent will fall from the delivery system as well.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use can lead to kink/bend the catheters, user technique when the device is removed from its package or advancing the device through the scope can kink the catheters, this condition can cause friction between the components at kinked/bent areas in the catheters, force retracting the pull wire/guide catheter in order to release the stent can result in guide catheter breaking, making that the stent falls from the delivery system as well.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.Block h11: correction to block a2: age at time of event; unit of measure - age.
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 common bile duct, performed on june 28, 2022.During the procedure, when the nurse attempted to deploy the stent and pulled back the guide catheter, the stent deployed prematurely and the guide catheter broke.The physician retrieved both the stent and guide catheter at the same time using a snare and decided not to place another stent to adequate the bile drainage.All broken pieces were removed from the patient and 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: 15090638
• Report Number: 3005099803-2022-03829
• Device Sequence Number: 3879027
• Product Code: FGE
• UDI-Device Identifier: 08714729252221
• UDI-Public: 08714729252221
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 07/18/2024
• Device Model Number: M00545650
• Device Catalogue Number: 4565
• Device Lot Number: 0027692038
• 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: 06/28/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 07/24/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 70 KG