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

Model Number	M00533580
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used in the bile duct to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, there was difficulty in deploying the stent.The nurse pulled hardly on the inner catheter, and it broke off into two pieces.A retrieval device was not required to remove the broken inner catheter from the patient.The procedure was completed with another naviflex delivery system.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks 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: imdrf device code a0401 captures the reportable event of catheter-guide break.
Additional Manufacturer Narrative
Blocks 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: imdrf device code a0401 captures the reportable event of catheter-guide break.Block h11: a naviflex rx delivery system was received for analysis.Visual inspection found the guide catheter kinked and detached.The pull wire was kinked.Destructive inspection found that the device hypotube from the pull wire detached the black guide catheter.No other problems were noted with the device.Product analysis confirmed the reported events of catheter-guide break and sten failure to deploy.The investigation concluded that the reported event of catheter-guide break was likely due to a quality control deficiency as it was found that the pull wire was not assembled deep enough into the black guide catheter.Boston scientific initiated a non-conforming events prevention (ncep) investigation in june 2024 to further evaluate "catheter guide break" events where the hypotube was not properly bonded to the inside of the guide catheter.The investigation found the guide catheter can slip within the grippers during the bonding cycle after the foot pedal is pushed to begin the cycle.If this is not identified during visual inspection by the operator, this can cause an insufficient bond between hypotube and guide catheter.An immediate action was taken to add a magnification tool to the manufacturing process to improve operator visualization of the bond during the required inspection, and all operators were reminded of the correct method for bond inspections.Although the advanix biliary stent with naviflex rx delivery system continues to perform within anticipated product performance expectations, boston scientific initiated a corrective and preventive action (capa) investigation to further investigate whether any additional corrective actions are warranted.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a manufacturing review did not identify any anomalies or deviations that could have contributed to the event.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used in the bile duct to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, there was difficulty in deploying the stent.The nurse pulled hardly on the inner catheter, and it broke off into two pieces.A retrieval device was not required to remove the broken inner catheter from the patient.The procedure was completed with another naviflex delivery system.There were no patient complications reported as a result of this event.

• Brand Name: NAVIFLEX RX DELIVERY SYSTEM
• 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: 19655887
• Report Number: 3005099803-2024-03112
• Device Sequence Number: 12516968
• Product Code: FGE
• UDI-Device Identifier: 08714729787105
• UDI-Public: 08714729787105
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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 Model Number: M00533580
• Device Catalogue Number: 3358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown