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

Model Number	M0062502280
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(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 was used during a procedure performed on (b)(6) 2018.According to the complainant, during preparation, it was noted that the coating of the sheath peeled off from the device.The procedure was completed with another navigator hd access sheath.No patient complications have been reported as a result of this event attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used during a procedure performed on (b)(6) 2018.According to the complainant, during preparation, it was noted that the coating of the sheath peeled off from the device.The procedure was completed with another navigator hd access sheath.No patient complications have been reported as a result of this event attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
A visual examination of the returned complaint device found a kink near the hub.Only the sheath was returned.The sheath was moistened with water and it became slippery, indicating that coating was applied on the device.The coating appeared to be uneven in some areas.The noted failure likely occurred due to handling/manipulation of the device during preparation that could have affected the device performance and its integrity; therefore, the most probable root cause is handling damage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.

• Brand Name: NAVIGATOR¿ HD
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; propark free zone; spencer IN 47460
• MDR Report Key: 7645650
• Report Number: 3005099803-2018-02098
• Device Sequence Number: 11215953
• Product Code: FED
• UDI-Device Identifier: 08714729839088
• UDI-Public: 08714729839088
• Combination Product (Y/N): N
• PMA/510(K) Number: K122649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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: 02/05/2020
• Device Model Number: M0062502280
• Device Catalogue Number: 250-228
• Device Lot Number: 21702000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1