MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIGATOR HD; CATHETER, UROLOGICAL

Model Number	M0062502210
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).Investigation results the device was not returned for analysis; therefore, the root cause of the reported coating problem cannot be confirmed.However, a media analysis was performed on the photo submitted by the customer, and it was found that the inner coating of the sheath was peeled.The root causes of the coating problem and inner coating of sheath peeled cannot be established as the product is not available for investigation and it was confirmed to have been disposed by the customer.Based on the available information and in the absence of device return, the root cause of the reported clinical observations cannot be established.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used in the kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2022.During the procedure, it was noticed that the coating seems to be peeling off.The procedure was completed with another of the same navigator hd access sheath.There were no patient complications reported as a result of this event.The patient outcome following the procedure was reported to be fully recovered.This event has been deemed reportable based on the investigation findings of inner coating of sheath was peeled.Please see device analysis results for full investigation details.Note: a photo showing one navigator hd access sheath was submitted by the customer.

• Brand Name: NAVIGATOR HD
• Common Device Name: CATHETER, UROLOGICAL
• 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: 15639189
• Report Number: 3005099803-2022-06059
• Device Sequence Number: 20262687
• Product Code: FED
• UDI-Device Identifier: 08714729839064
• UDI-Public: 08714729839064
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K030956
• 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
• Report Date (Section B): 10/20/2022

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 Model Number: M0062502210
• Device Catalogue Number: 250-221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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