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

Model Number M0062502220

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to one of two navigator hd access sheath devices used in the same patient and procedure.It was reported to boston scientific corporation that two navigator hd access sheath devices were used in the kidney during a ureteroscopy procedure performed on (b)(6) 2021.During the procedure, the plastic part of the sheath broke when the scope was passed through the device.The same issue occurred with the second navigator hd access sheath.The procedure was completed with another navigator hd access sheath devices.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.Block h2: additional information: block b5 (describe event or problem) conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: correction: h6 (device codes).

Event Description

Note: this report pertains to one of two navigator hd access sheath devices used in the same patient and procedure.It was reported to boston scientific corporation that two navigator hd access sheath devices were used in the kidney during a ureteroscopy procedure performed on (b)(6) 2021.During the procedure, the plastic part of the sheath broke when the scope was passed through the device.The same issue occurred with the second navigator hd access sheath.The procedure was completed with another navigator hd access sheath devices.There were no patient complications reported as a result of this event.***additional information received on (b)(6) 2021*** it was clarified that it was the white proximal hub of the device which was broken.

• Brand Name: NAVIGATOR HD
• Type of Device: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12655648
• MDR Text Key: 277122972
• Report Number: 3005099803-2021-05277
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1