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

Model Number	M0062502230
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
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 device was unpacked to be used in the left kidney for a retrograde intrarenal surgery (rirs) procedure on (b)(6) 2021.During preparation, it was noted that the distal tip of the catheter was broken.The procedure was completed with another navigator access sheath.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath device was unpacked to be used in the left kidney for a retrograde intrarenal surgery (rirs) procedure on (b)(6) 2021.During perparation, it was noted that the distal tip of the catheter was broken.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: device code a04 aptures the reportable event of access sheath tip broken.Block h10: investigation result visual examination found that the sheath and dilator was observed to have the tip kinked/bent.Functional analysis was able to be performed, the dilator was able to be removed and re-inserted in the sheath without any issue.Media analysis of the photo submitted by the customer shows the sheath and dilator tip kinked/bent.It is most likely that the operational factors, such as manipulation of the device during transport/storage can lead to the found problem, generating the dilator tip was kinked/bent.It's most probable that the way in which the device was handled and manipulated during the processes of shipping/receiving and/or storage could have caused this problem and consequently affect the performance of the device; therefore the most probable root cause is cause traced to transport/storage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 12172316
• Report Number: 3005099803-2021-03570
• Device Sequence Number: 14292051
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: 08714729837985
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/12/2021

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: 06/27/2022
• Device Model Number: M0062502230
• Device Catalogue Number: 250-223
• Device Lot Number: 0025648101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR