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

Model Number	M0062502280
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure 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 access sheath was used during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2021.During the procedure, when packaging was unpacked to prepare the device, coating was found to be defective.The procedure was completed with another navigator access sheath.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device code a040506 captures the reportable issue of sheath peeled.Block h10: investigation result: a visual examination of the returned device noted that the sheath and dilator was free of obvious kinks and bends.It was also noted that there was evidence of coating in the sheath.Functional inspection was performed and the sheath and dilator surfaces were moistened with water and they became slippery, indicating that the coating was applied on both devices, the reported complaint is not confirmed.A microscope inspection was also performed under magnification and it observed that the surface of the sheath had coating residues.No other issues were noted on the device.As there was no issue with the visual and functional test during product analysis, the complaint incident cannot be confirmed.The most probable root cause of the reported event therefore cannot be detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2021.During the procedure, when packaging was unpacked to prepare the device, coating was found to be defective.The procedure was completed with another navigator access sheath.There were no patient complications reported as a result of this event.Additional information received on august 10, 2021: it was noted that the outer part of the sheath peeled off.

• 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
• MDR Report Key: 12294520
• Report Number: 3005099803-2021-04060
• Device Sequence Number: 3180930
• Product Code: FED
• UDI-Device Identifier: 08714729839088
• UDI-Public: 08714729839088
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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: 03/15/2023
• Device Model Number: M0062502280
• Device Catalogue Number: 250-228
• Device Lot Number: 0026974062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1