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

Model Number	M0062502230
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used in the ureter during a flexible ureteroscopy (furs) procedure performed on (b)(6) 2021.During the extraction of a stone fragment, it was noticed that the internal lining of the sheath was partially detached.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 good.
Additional Manufacturer Narrative
Block h6: medical device problem code a040506 captures the reportable event of sheath peeled.Block h10: investigation result.A visual examination of the returned complaint device found that the sheath was bent in the middle section and a scratch marks were also observed.It was also noticed that one container with a liquid inside of it was returned with the device which showed no evidence of the report allegation.Functional analysis was performed by moistening the device sheath surfaces with water and it became slippery which indicated that a coating was applied on the device.The reported event of sheath peeled was not confirmed.Pertaining to the found problem of sheath kinked and scratched, it is possible that some operational factors, such as handling or manipulation of the device during use, excess of force, interaction with the anatomy or other devices could have caused these problems and consequently affected the device performance and its intended purpose.Therefore, the most probable root cause for the sheath kinked and scratched is adverse event related to procedure.However, because the reported problem of the sheath peeled was not confirmed, the root cause cannot be determined.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.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 ureter during a flexible ureteroscopy (furs) procedure performed on (b)(6) 2021.During the extraction of a stone fragment, it was noticed that the internal lining of the sheath was partially detached.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 good.
Additional Manufacturer Narrative
Block h6: medical device problem code a040506 captures the reportable event of sheath peeled.Block h10: investigation result: a visual examination of the returned complaint device found that the sheath was bent in the middle section and a scratch marks were also observed.It was also noticed that a container with a liquid inside of it was returned with the device and there was no evidence of internal lining of the sheath inside of it.Therefore, the reported event of partial detachment of the internal lining of the sheath was not confirmed.Functional analysis was performed by moistening the device sheath surfaces with water and it became slippery which indicated that a coating was applied on the device.Pertaining to the found problem of sheath kinked and scratched, it is possible that some operational factors, such as handling or manipulation of the device during use, excess of force, interaction with the anatomy or other devices could have caused these problems and consequently affected the device performance and its intended purpose.Therefore, the most probable root cause for the sheath kinked and scratched is adverse event related to procedure.However, because the reported problem of the sheath peeled was not confirmed, the root cause cannot be determined.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.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 ureter during a flexible ureteroscopy (furs) procedure performed on (b)(6) 2021.During the extraction of a stone fragment, it was noticed that the internal lining of the sheath was partially detached.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 good.

• 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: 12532051
• Report Number: 3005099803-2021-05044
• Device Sequence Number: 16477625
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: 08714729837985
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2021

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: 10/28/2021
• Device Model Number: M0062502230
• Device Catalogue Number: 250-223
• Device Lot Number: 0024672904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 10/01/2021; 11/18/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/25/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2019
• 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