MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX PANCREATIC STENT KIT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00537520
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial reporter facility state/province: (b)(6).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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during an endoscopic retrograde cholangiopancreatography (ercp) in the common bile duct and pancreatic duct, performed on (b)(6) 2020.According to the complainant, during the preparation, when the stent was taken out from the packaging, the stent got caught in the plastic box, leading the stent to be flattened and deformed.The procedure was successfully completed with another advanix pancreatic stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code 2976 captures for the reportable event of stent deformed.Block e1: (b)(6).Block h10: the returned advanix pancreatic stent kit (stent and pusher ) was analyzed.A visual evaluation noted the pusher was free of obvious kinks and bends, it did not have any visual damage.The stent was deformed at proximal section where the barbs are located.The original packages were not returned with the devices (pouches, stent tray and tray lid).No other issues with the device were noted.The reported event was confirmed.According to the analysis of the device and the information in the event description, the stent got kinked on the flaps is consequently, confirming the reported complaint of stent material deformation; however, the package (pouches, stent tray and tray lid) was not returned for analysis, therefore no conclusion could be made for the package failure to remove.It is most likely the manipulation during removal, interaction of the packaging and other procedural factors could have affected the device integrity causing the experienced event of stent damaged.Therefore the most probable root cause for this event is "adverse event related to procedure." a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during an endoscopic retrograde cholangiopancreatography (ercp) in the common bile duct and pancreatic duct, performed on (b)(6) 2020.According to the complainant, during the preparation, when the stent was taken out from the packaging, the stent got caught in the plastic box, leading the stent to be flattened and deformed.The procedure was successfully completed with another advanix pancreatic stent.There were no patient complications reported as a result of this event.

• Brand Name: ADVANIX PANCREATIC STENT KIT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9775978
• Report Number: 3005099803-2020-00631
• Device Sequence Number: 2288858
• Product Code: FGE
• UDI-Device Identifier: 08714729856290
• UDI-Public: 08714729856290
• 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): 05/07/2020

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: 11/23/2020
• Device Model Number: M00537520
• Device Catalogue Number: 3752
• Device Lot Number: 0023902679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1