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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAVIGATOR HD; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
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NAVIGATOR HD; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY Back to Search Results
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 10/12/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used in the ureter during a ureterolithotomy procedure performed on (b)(6) 2021.During the procedure, the sheath was fractured in half.The procedure was completed with another navigator hd access sheath device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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 medwatch will be filed.
 
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Brand Name
NAVIGATOR HD
Common Device Name
ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
MDR Report Key12754015
Report Number3005099803-2021-05714
Device Sequence Number1454803
Product Code FED
UDI-Device Identifier08714729837978
UDI-Public08714729837978
Combination Product (Y/N)N
Initial Reporter CountryCO
PMA/510(K) Number
K140323
Number of Events Summarized1
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
Report Date (Section B) 11/04/2021
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 Date11/19/2021
Device Model NumberM0062502220
Device Catalogue Number250-222
Device Lot Number0024802624
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/13/2021
Initial Report FDA Received Date11/04/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured11/20/2019
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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