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

Model Number	M0062502230
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
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 was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, during preparation, the sheath was found broken in half when removed from the package.The procedure was completed with another navigator hd access sheath.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 4008 captures the reportable issue of product broke in half.Block h10: investigation result only the sheath of the navigator device was received and the dilator was not returned.A physical examination of the complaint device revealed that the sheath was broken.It was also noted that there were whitened areas indicating that the device was submitted to tension forces, also there is evidence of bending adjacent the whitened areas.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.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 access sheath was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, during preparation, the sheath was found broken in half when removed from the package.The procedure was completed with another navigator hd access sheath.There were 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: 9418839
• Report Number: 3005099803-2019-05845
• Device Sequence Number: 13574297
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: 08714729837985
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 05/29/2021
• Device Model Number: M0062502230
• Device Catalogue Number: 250-223
• Device Lot Number: 0023876520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1