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

Model Number	M0062502280
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
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 urinary bladder during a cystoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the surgeon noticed that the end of the access sheath feels rough.Reportedly, the access sheath possibly caused a laceration/tear in the patients ureter.The laceration was stitched and monitored after.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used in the urinary bladder during a cystoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the surgeon noticed that the end of the access sheath feels rough.Reportedly, the access sheath possibly caused a laceration/tear in the patients ureter.The laceration was stitched and monitored after.
Additional Manufacturer Narrative
Problem code 2987 captures the reportable event of sheath damaged.Investigation results a visual examination of the returned complaint device found that no visual defects were noted and was under good conditions without evidence of damages.It was also noted that the there were no irregularities, rough, sharp or pointed sections on the tip or any other surface.The device cannot be evaluated with respect to procedural factors encountered during its use, consequently, not confirming the reported complaint.Therefore, the most probable root cause for this complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/20/2018 12:07 pm ct.The report number is being corrected from: 3005099803-2018-62143 to: 3005099803-2018-61348.

• 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: 8066186
• Report Number: 3005099803-2018-61348
• Device Sequence Number: 13941476
• Product Code: FED
• UDI-Device Identifier: 08714729839088
• UDI-Public: 08714729839088
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2020
• Device Model Number: M0062502280
• Device Catalogue Number: 250-228
• Device Lot Number: 0022013990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR