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

Model Number M00533560

Device Problems Break (1069); Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device problem code a0401 captures the reportable investigation result of guide catheter detached/separated.The returned naviflex delivery system was analyzed, visual evaluation noted that the pull wire was completely retracted.The working length was kinked in distal section.The guide catheter was returned detached.Functional evaluation was performed; however, the guide catheter did not retract.The device was disassembled, the guide wire was pulled out, and was found detached.No other problems with the device were noted.Taking all available information into consideration, the investigation concluded that most likely the reported event and observed failures were due to procedural or anatomical factors encountered during the procedure.User manipulation and technique performed during the procedure and/or anatomical factors could have contributed to the push catheter kinked.Once the push catheter is kinked, this condition can cause the user to apply additional force/tension and as a consequence, guide catheter detachment.Therefore, the most probable root cause is adverse event related to the procedure.

Event Description

It was reported to boston scientific corporation that a naviflex rx delivery system was used during an endoscopic retrograde cholangiopancreatography (ercp) in the bile duct performed on (b)(6) 2022.During procedure and outside the patient, it was noted that the device would not pull back.Another naviflex delivery system was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Investigation results revealed the guide catheter was detached/separated; therefore, this event has been deemed a reportable event.

• Brand Name: NAVIFLEX RX DELIVERY SYSTEM
• Type of Device: 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: 16293239
• MDR Text Key: 308755323
• Report Number: 3005099803-2023-00374
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: 08714729787082
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00533560
• Device Catalogue Number: 3356
• Device Lot Number: 0029683831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1