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

Model Number	M0062502220
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2021
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 hd access sheath device was unpacked for a flexible ureteroscopy (urs) procedure performed on (b)(6) 2021.During unpacking, it was noticed that the sterile device pouch was already unsealed and open.There was no problem noted to the device.The unsealed packaging was confirmed via a photo sent by the customer.The procedure was completed with another navigator hd access sheath device.There have been no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a020503 captures the reportable issue of package seal already open.Block h10: a visual examination of the complaint device found that only a part of the original pouch was returned.The returned part was found cut at both ends of the pouch and was opened, thereby confirming the reported event.It was also possible to observed an evidence of seal process.The returned navigator device did not have any visual defects and were in a good condition.This failure is likely due to factors or conditions related to procedure during the use of the device, such as handling and manipulation manipulation that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.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 instruction for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath device was unpacked for a flexible ureteroscopy (urs) procedure performed on (b)(6), 2021.During unpacking, it was noticed that the sterile device pouch was already unsealed and open.There was no problem noted to the device.The unsealed packaging was confirmed via a photo sent by the customer.The procedure was completed with another navigator hd access sheath device.There have been no patient complications reported as a result of this event.

• 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: 11811825
• Report Number: 3005099803-2021-02163
• Device Sequence Number: 16934240
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 07/26/2021

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: 10/09/2022
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Device Lot Number: 0026162287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1