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

Model Number	M00533570
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a naviflex delivery system was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6), 2022.During the procedure, when the physician attempted to deploy the stent, the inner sheath was detached/separated.Another naviflex delivery system was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex delivery system was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, the inner sheath was detached/separated.Another naviflex delivery system was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of guide catheter break.Block h10: the returned naviflex rx delivery system was analyzed, and a visual evaluation noted that push catheter was kinked/bent.A functional inspection of the device was performed, the device was actuated; however, the guide catheter did not come out of the push catheter.The push catheter was then cut in order to inspect the internal components.It was noted that the guide catheter was detached from the delivery system and not returned, and the pull wire was kinked.Based on the device analysis, the reported event of guide catheter detached/separated was confirmed.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 procedure.These factors could have affected the device performance and integrity.Patient anatomy and customer maneuvering during the use of the device can lead to a kink in the push catheter and pull wire.Once the push catheter is kinked, this condition can cause resistance when retracting the pull wire and guide catheter detachment due to friction between the components at the kinked areas.Therefore, the most probable root cause is adverse event related to the procedure.

• 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: 15750624
• Report Number: 3005099803-2022-06373
• Device Sequence Number: 16870707
• Product Code: FGE
• UDI-Device Identifier: 08714729787099
• UDI-Public: 08714729787099
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 12/23/2022

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: 03/29/2024
• Device Model Number: M00533570
• Device Catalogue Number: 3357
• Device Lot Number: 0029139873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown