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

Model Number	M0062502250
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/12/2018
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 ureteral access sheath was unpacked on (b)(6) 2018.According to the complainant, during preparation, a trace of blood like stain was noted on the box.Reportedly, there were no damages noted on the packaging.Additionally, this was not used in a patient.
Additional Manufacturer Narrative
(b)(4).An unused navigator hd was returned for analysis.A visual examination of the returned complaint device found that the box had foreign matter like a drop stain and blue marks on the outer side of the box.The box also had signs of manipulation in some areas (wrinkles).The closure strip was intact.This failure is likely due handling and excessive manipulation of the device during transport/storage which could have contributed with the encountered issues (a drop stain, blue marks and package wrinkled).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.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd ureteral access sheath was unpacked on (b)(6) 2018.According to the complainant, during preparation, a trace of blood like stain was noted on the box.Reportedly, there were no damages noted on the packaging.Additionally, this was not used in a patient.

• 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: 7929639
• Report Number: 3005099803-2018-60686
• Device Sequence Number: 1936939
• Product Code: FED
• UDI-Device Identifier: 08714729837992
• UDI-Public: 08714729837992
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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: 04/18/2020
• Device Model Number: M0062502250
• Device Catalogue Number: 70388
• Device Lot Number: 0022013991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 10/31/2018
• Patient Sequence Number: 1