MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIFLEX RX PUSHER; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00535010
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 naviflex rx pusher was to be used in an unknown procedure in the pancreas performed on (b)(6) 2018.According to the complainant, when the naviflex rx pusher was inserted over the guidewire, resistance was met at the area where the guidewire came out from the naviflex rx pusher.When the device was pushed, a cotton-like object at the tail side of the guidewire came out from the lumen of the pusher.The source of the object was unknown.The procedure was completed with another of the same device.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 naviflex rx pusher was to be used in an unknown procedure in the pancreas performed on (b)(6) 2018.According to the complainant, when the naviflex rx pusher was inserted over the guidewire, resistance was met at the area where the guidewire came out from the naviflex rx pusher.When the device was pushed, a cotton-like object at the tail side of the guidewire came out from the lumen of the pusher.The source of the object was unknown.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual analysis found no visual defects were noted.The device looks under good conditions without evidence of damages or anomalies, the product was specifically inspected looking for any foreign matter and it was not found any non-conformity.A functional inspection was performed, the device was backloaded over a 0.035" guidewire, the device was able to be advanced trough it without problems or resistance until the guidewire exited by the guidewire exit port.Therefore, no problem detected is selected as the most probable root cause for the complaint.A dhr (device history record) review was performed and no deviation was found.

• Brand Name: NAVIFLEX RX PUSHER
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8060485
• Report Number: 3005099803-2018-61355
• Device Sequence Number: 14139524
• Product Code: FGE
• UDI-Device Identifier: 08714729856214
• UDI-Public: 08714729856214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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: 10/06/2019
• Device Model Number: M00535010
• Device Catalogue Number: 3501
• Device Lot Number: 0021963463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1