MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIGATOR HD; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	M0062502230
Medical Device Problem Codes	Difficult to Insert (1316); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation result of sheath fractured.Block h10: investigation result the returned navigator access sheath was analyzed, and a visual evaluation noted that the sheath and dilator were bent in the middle.Functional evaluation was performed, and the device sheath and dilator surfaces were moistened with water, and the dilator became slippery indicating coating was applied.It was also noted that some areas of the sheath became slippery but some other areas of the surface of the sheath felt dry.Microscopic examination was performed, and the sheath was observed before it was moistened with water and after moistened.It was noticed that there were different section without coating in the sheath.Additionally, the sheath was fractured near the distal end and a whitened area was observed at the fracture site, indicating the material was submitted to tension.Dimensional examination was performed on the outer diameter of the sheath, and it was found to be within specification.No other problems with the device were noted.The reported event of coating not successively smooth was confirmed.Based on the investigation, the sheath was found with voids without coating and stiffness was felt.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however, there is no control over how the devices are handled/manipulated in the field.It was reported that the physician soaked the outer sheath with normal saline and checked it with his hand.As per replicate, if force is applied on the sheath surface once the device coating is activated, the coating can be removed, causing voids along the sheath.The encountered failure was able to be re-created.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.It is possible that the force applied during the manipulation on the device once it had the coating activated cause the voids on the sheath, once voids are in the sheath, the device can find itself difficulties for insertion, affecting the performance of the device.Additionally, the operational factors during the preparation or set up of the device, could have cause tension in the sheath and dilator, occasioning the bent/kinks observed and leading to the fracture encountered.Therefore, the most probable root cause is unintended use error caused or contributed to event.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was prepared for use in the kidney to treat a 3cm stone during a soft ureteroscopic procedure performed on (b)(6) 2022.During the preparation, the physician soaked the outer sheath with normal saline; however, it was felt that the coating was not successively smooth.There was resistance in the process of entering the sheath.The procedure was completed with another navigator hd access sheath.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.This event has been deemed reportable based on analysis of the returned device which found that the sheath fractured near distal end.Please see block h10 for full investigation details.

• Brand Name: NAVIGATOR HD
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• 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: 17324149
• Report Number: 3005099803-2023-03613
• Device Sequence Number: 6319650
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: 08714729837985
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140323
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2023

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: 03/01/2024
• Device Model Number: M0062502230
• Device Catalogue Number: 250-223
• Device Lot Number: 0028971599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2022
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 75 KG