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

Model Number	M0062502220
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath device was used during a procedure performed on an unknown date.During the procedure, the navigator hd breaks while inside the patient.There were no patient complications reported as a result of this event.Note: the customer provided two photos; one showed the navigator sheath (split into two) and the dilator inside a red plastic bag.Another showed the device's original pouch.It was observed that the inner wire was stretched out and the sheath had bending marks.
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.Health professional was approximated to yes as the initial reporter name and occupation are unknown, but the event was reported to have occurred at a health care facility.(b)(4).The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.(b)(4).
Additional Manufacturer Narrative
Block b3: date of event was approximated to 07/01/2022 based on the date the manufacturer became aware of the event.Block h6: medical device code a0414 captures the reportable event of sheath torn.Block h10: the complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Additional information: block b5 (procedure outcome), block e1 (initial reporter's name and title), block e3 (initial reporter's occupation).
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath device was used during a procedure performed on an unknown date.During the procedure, the navigator hd breaks while inside the patient.There were no patient complications reported as a result of this event.Additional information received on july 15, 2022 stated that there were no further complications with the procedure as an outcome of the broken device.Additionally, the procedure was successfully completed after using a new navigator hd device.

• 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
• 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: 15051082
• Report Number: 3005099803-2022-03806
• Device Sequence Number: 5515236
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 05/05/2024
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Device Lot Number: 0029351381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown