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

Model Number	M0062502260
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used in the kidney during a lithotripsy procedure performed on (b)(6) 2021.During the procedure, it was noticed that the tube in the sheath was peeled off.Reportedly, no piece of the device detached inside the patient.The procedure was completed with another navigator 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.
Additional Manufacturer Narrative
Block h6: device code a040506 captures the reportable issue of sheath peeled.Block h10: investigation results: visual examination of the returned complaint device found that both the sheath and dilator were bent.It was also noted that the inner lining of the sheath protruded from the tip of the sheath.It is probably that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use can lead to kink/bend of the device, once the sheath is kinked/bent it can affect the overall performance of the device making additional devices/tools to rub the inner walls of the sheath and it can damage the inner lining of the sheath contributing with the event reported.Therefore, the most probable root cause is adverse event related to procedure.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 in the kidney during a lithotripsy procedure performed on may 26, 2021.During the procedure, it was noticed that the tube in the sheath was peeled off.Reportedly, no piece of the device detached inside the patient.The procedure was completed with another navigator 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.

• 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: 12020578
• Report Number: 3005099803-2021-02958
• Device Sequence Number: 17000571
• Product Code: FED
• UDI-Device Identifier: 08714729837558
• UDI-Public: 08714729837558
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 07/23/2022
• Device Model Number: M0062502260
• Device Catalogue Number: 250-226
• Device Lot Number: 0025761515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 78