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

Model Number	M00535000
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx pusher advanix pancreatic stent was to be used to treat stones in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During preparation, hair was found inside the device packaging.There were no patient complications reported as a result of this event.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.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 a180104 captures the reportable event of foreign material present in device.
Additional Manufacturer Narrative
Blocks b5, d4 (lot number, expiration date), and h4 have been updated with additional information received on may 13, 2024.Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx pusher advanix pancreatic stent was to be used to treat stones in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During preparation, hair was found inside the device packaging.There were no patient complications reported as a result of this event.Additional information received on may 13, 2024: the procedure was completed with another of the same device.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx pusher advanix pancreatic stent was to be used to treat stones in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During preparation, hair was found inside the device packaging.There were no patient complications reported as a result of this event.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Blocks b5, d4 (lot number, expiration date), and h4 have been updated with additional information received on may 13, 2024.Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.Block h11: an advanix biliary stent with naviflex rx delivery system was received for analysis.Visual examination of the returned device found the device's pouch is closed and there is a hair inside the pouch.The reported event of foreign material present in device was confirmed.Based on all the available information, the cause of the reported foreign material was likely due to a manufacturing deficiency.Boston scientific initiated a non-conforming events prevention (ncep) investigation to further investigate the foreign material present in device event.The ncep investigation concluded that the event was an isolated event due to human error during the manufacturing of lot 0031507911.A review of the manufacturing process found it likely that a step in the procedure was not followed.Per the cosmetic inspection procedure, hair is not allowed on the product and/or component.All applicable product builders were made aware of the event and the procedure was reviewed by all applicable product builders to heighten awareness of the requirements outlined in this manufacturing process.

• Brand Name: NAVIFLEX RX PUSHER
• 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: 19297569
• Report Number: 3005099803-2024-02210
• Device Sequence Number: 20553727
• Product Code: FGE
• UDI-Device Identifier: 08714729856207
• UDI-Public: 08714729856207
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133700
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024

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 Expiration Date: 10/26/2024
• Device Model Number: M00535000
• Device Catalogue Number: 3500
• Device Lot Number: 0031507911
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 05/13/2024; 06/18/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/06/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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