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

Model Number	M0062502260
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
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 for a procedure on (b)(6) 2021.During preparation, it was noted that the outer box of the product was damaged.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h2: additional information: block e3 (occupation).Block h6: device code a0205 captures the reportable event of package damage.Block h10: 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 for a procedure on (b)(6) 2021.During preparation, it was noted that the outer box of the product was damaged.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 12420800
• Report Number: 3005099803-2021-04592
• Device Sequence Number: 3308471
• Product Code: FED
• UDI-Device Identifier: 08714729837558
• UDI-Public: 08714729837558
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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: 06/20/2023
• Device Model Number: M0062502260
• Device Catalogue Number: 250-226
• Device Lot Number: 0027525485
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/27/2021
• Patient Sequence Number: 1