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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
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BOSTON SCIENTIFIC CORPORATION AXIOS; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE Back to Search Results
Model Number M00553650
Device Problems Premature Activation (1484); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2019
Event Type  malfunction  
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 Description
It was reported to boston scientific corporation that a hot axios stent was to be implanted to treat a pancreatic pseudocyst during a pancreatic pseudocyst drainage procedure performed on (b)(6) 2019.According to the complainant, during the procedure, as the guidewire was being advanced through the axios device, the guidewire kinked inside the axios catheter, and the hydrophilic coating stripped off of the guidewire revealing the metal in the center.When the physician exchanged guidewires, the axios stent was partially deployed inside the patient, so the physician removed the axios device from the patient.Another guidewire and another hot axios stent were used to complete the procedure.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a hot axios stent was to be implanted to treat a pancreatic pseudocyst during a pancreatic pseudocyst drainage procedure performed on (b)(6) 2019.According to the complainant, during the procedure, as the guidewire was being advanced through the axios device, the guidewire kinked inside the axios catheter, and the hydrophilic coating stripped off of the guidewire revealing the metal in the center.When the physician exchanged guidewires, the axios stent was partially deployed inside the patient, so the physician removed the axios device from the patient.Another guidewire and another hot axios stent were used to complete the procedure.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Device code 1484 captures the reportable event of stent first flange premature deployment.A hot axios stent and delivery system was returned for analysis.A visual examination of the device noted that sheath was pulled back slightly from the nosecone exposing the distal end of the stent.The stent deployment hub was in its original position, the catheter hub was moved proximally, and the catheter lock was in the locked position.The yellow safety clip was not returned.A functional evaluation was performed, and the catheter hub advanced and retracted without resistance.The stent deployment hub was also able to be moved without resistance.The stent was able to be fully deployed without any resistance or issue.The stent was measured to be within specifications.There were no other issues noted.The reported deployment issues indicate operational difficulties experienced during the procedure and are likely due to anatomical or procedural factors.Some echoendoscope and elevator positions result in excess friction between the catheter and the working channel.Friction can impact the performance of the device.Procedural factors, such as the handling of the device and normal procedural difficulties encountered during the procedure, could have possibly affected the device performance and its integrity contributing to the reported event.Therefore, a review and analysis of all available information indicated that the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.
 
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Brand Name
AXIOS
Type of Device
PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9117530
MDR Text Key160179116
Report Number3005099803-2019-04693
Device Sequence Number1
Product Code PCU
UDI-Device Identifier08714729904595
UDI-Public08714729904595
Combination Product (y/n)N
PMA/PMN Number
K153088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/25/2021
Device Model NumberM00553650
Device Catalogue Number5365
Device Lot Number0023401482
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2019
Date Manufacturer Received10/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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