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

Model Number	M0062502230
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result: visual examination found that the sheath was torn in two different section and the dilator was bent.Media analysis of the photo submitted by the customer confirmed the sheath torn and dilator in a good condition.It is most likely that the damage observed are problem that could have been generated by the user or due to the storage or transport (weather/light, ultraviolet light / exposition to organic solvents/ ionizing radiation) of the package; 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.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was unpacked for a flexible ureteroscopy procedure performed on (b)(6) 2021.During preparation, it was noted that the device was in a poor condition.Photo submitted by the customer confirmed that the sheath was torn.The procedure was completed with another navigator access sheath.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was unpacked for a flexible ureteroscopy procedure performed on (b)(6), 2021.During preparation, it was noted that the device was in a poor condition.Photo submitted by the customer confirmed that the sheath was torn.The procedure was completed with anothernavigator access sheath.There were no patient complications reported as a result of this event.**correction** during preparation, it was noted that the device was in a poor condition.The procedure was completed with another navigator access sheath.This event has been deemed a reportable event based on the investigation finding of sheath torn.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block h6: problem code a0414 captures the reportable event of sheath torn.Block h10: investigation result visual examination found that the sheath was torn in two different section and the dilator was bent.Media analysis of the photo submitted by the customer confirmed the sheath torn and dilator in a good condition.It is most likely that the damage observed are problem that could have been generated by the user or due to the storage or transport (weather/light, ultraviolet light / exposition to organic solvents/ ionizing radiation) of the package; 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.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.Block h11 correction: blocks b1 (adverse event/product problem), b5 (describe event or problem) and h6 (device code).

• 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: 12605194
• Report Number: 3005099803-2021-05243
• Device Sequence Number: 11080434
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: 08714729837985
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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: 11/03/2021
• Device Model Number: M0062502230
• Device Catalogue Number: 250-223
• Device Lot Number: 0024706803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 60