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

Model Number	M00535060
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Device Dislodged or Dislocated (2923); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during an endoscopic retrograde cholangiopancreatography procedure in the pancreatic duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, resistance was severe and the pullwire was bent.When the pullwire was pulled out with force, the handle of the guide catheter came off and the pullwire was dislodged and was exposed.The delivery system was grasped with pliers to position the stent.The stent was deployed successfully and completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during an endoscopic retrograde cholangiopancreatography procedure in the pancreatic duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, resistance was severe and the pullwire was bent.When the pullwire was pulled out with force, the handle of the guide catheter came off and the pullwire was dislodged and was exposed.The delivery system was grasped with pliers to position the stent.The stent was deployed successfully and completed the procedure.There were no patient complications reported as a result of this event.Additional information received on september 15, 2022: did the pullwire poke/pierced the guide catheter? no; or did the pullwire poke/pierce the push catheter? no.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block h6: medical device problem code a0401 captures the reportable event of guide catheter break.Block h10: the returned advanix pancreatic delivery system was analyzed, and a visual evaluation noted that the device was kinked in different sections of the push catheter.The pull wire was dislodged and kinked in different sections.The guide catheter and pull wire cap was not returned for analysis, and this suggested that both components were detached.Due to the damaged presented in the device it was not possible to perform a functional inspection.Although the device is a delivery system and there was not a returned stent, the damage found on the delivery system suggest that the customer could felt some difficulties trying to position stent.No other problems with the device were noted.The reported event was confirmed.According to the product analysis, the most relevant information of the complaint event description, device analysis and including 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 most likely that during the procedure user manipulation or some tension caused either by the physician's technique and/or even by tortuous anatomy caused the kinks on the push catheter and pull wire, once both parts were kinked the user may have experienced difficulties while pulling out the guide catheter which took the user to apply an extra force and dislodged the pull wire, finally could have detaching the pull wire cap and the guide catheter; as consequence the costumer had problems to retract the pull wire.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.
Additional Manufacturer Narrative
Block e1: initial reporter address 1 (b)(6).Block h6: medical device problem code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during an endoscopic retrograde cholangiopancreatography procedure in the pancreatic duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, resistance was severe and the pullwire was bent.When the pullwire was pulled out with force, the handle of the guide catheter came off and the pullwire was dislodged and was exposed.The delivery system was grasped with pliers to position the stent.The stent was deployed successfully and completed the procedure.There were no patient complications reported as a result of this event.Additional information received on september 15, 2022: did the pullwire poke/pierced the guide catheter? no; or did the pullwire poke/pierce the push catheter? no.

• 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: 15428774
• Report Number: 3005099803-2022-05042
• Device Sequence Number: 4750170
• Product Code: FGE
• UDI-Device Identifier: 08714729856221
• UDI-Public: 08714729856221
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 11/22/2022

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: 10/31/2023
• Device Model Number: M00535060
• Device Catalogue Number: 3506
• Device Lot Number: 0029335146
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 09/15/2022; 10/27/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/11/2022; 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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