MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ADVANIX¿ PANCREATIC STENT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00536520
Medical Device Problem Codes	Kinked (1339); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).A visual evaluation of the returned device found that the stent had several damages and slight kinks through it.A functional evaluation was performed and the pull wire of the naviflex (tw4267888) could be retracted without issues and the stent was deployed.Based on the product analysis, it is likely that during the procedure, the device could have been manipulated.Moreover, the failures found (stent damaged and slightly kinks through it) are issues that could have been generated by excessive manipulation of the device by the user, tortuous anatomy, the interacting with the scope or the interacting with other devices, and the failures encountered in the stent would cause difficulty with deploying stent in the correct location.Therefore the most probable root cause of this complaint is operational context, since it is most likely that due to anatomical and/or procedural factors encountered during the procedure, performance was limited.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific that an advanix pancreatic stent was used during an endoscopic retrogade cholangiopancreatography (ercp) procedure in common bile duct.According to the complainant, a dilation was being performed on a patient that has pancreatic duct stenosis due to chronic pancreatis.During the dilation, the physician attempted to deploy the advanix pancreatic stent, however it was hard to release the stent and when the catheter was forcibly pulled, the stent missed the target lesion.The guidewire was unable to be inserted completely back into the pancreas.The stent was removed from the patient and was reloaded onto the delivery system , however, the procedure could not be completed with this 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 "no problem".This event has been deemed a reportable event based on the investigation results; stent kinked, stent deformed.

• Brand Name: ADVANIX¿ PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6186467
• Report Number: 3005099803-2016-03868
• Device Sequence Number: 82331
• Product Code: FGE
• UDI-Device Identifier: 08714729857464
• UDI-Public: (01)08714729857464(17)20170731(10)18852214
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 12/01/2016

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: 07/31/2017
• Device Model Number: M00536520
• Device Catalogue Number: 3652
• Device Lot Number: 18852214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2016
• Initial Report FDA Received Date: 12/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1