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

Model Number	M00537360
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Initial reporter facility name: (b)(6).(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 an advanix pancreatic stent kit was used during a pancreatic stent placement in the pancreatic duct performed on (b)(6) 2020.According to the complainant, during the preparation, when the physician passed the stent through the pusher, it was noticed that the stent was deformed.The procedure was completed with another advanix pancreatic stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: initial reporter facility name: (b)(6) block h6: device code 2976 captures the reportable event of stent material deformation.Block h10: product analysis the returned advanix pancreatic was analyzed, and a visual evaluation noted that the stent had a kink in the pigtail section of the stent.The reported event was confirmed.It is possible that operational factors, such as user technique/handling during preparation or testing, contributed to the observed stent kink issue.Handling or customer maneuvering, while the guidewire is being advanced inside the stent, can bend the stent, also force applied to the device to advance the guide catheter during preparation can lead to the observed failure, this condition could have affected the device integrity and generating the reported complaint issue of stent material deformation.Therefore, the most probable root cause 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 kit was used during a pancreatic stent placement in the pancreatic duct perforned on (b)(6), 2020.According to the complainant, during the preparation, when the physician passed the stent through the pusher, it was noticed that the stent was deformed.The procedure was completed with another advanix pancreatic stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: initial reporter facility name: (b)(6) block h6: device code 2976 captures the reportable event of stent material deformation.Block h10: product analysis the returned advanix pancreatic was analyzed, and a visual evaluation noted that the stent had a kink in the pigtail section of the stent.The reported event was confirmed.It is possible that operational factors, such as user technique/handling during preparation or testing, contributed to the observed stent kink issue.Handling or customer maneuvering, while the guidewire is being advanced inside the stent, can bend the stent, also force applied to the device to advance the guide catheter during preparation can lead to the observed failure, this condition could have affected the device integrity and generating the reported complaint issue of stent material deformation.Therefore, the most probable root cause 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.Block h11: updated block d4: m00537360.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent kit was used during a pancreatic stent placement in the pancreatic duct perforned on (b)(6) 2020.According to the complainant, during the preparation, when the physician passed the stent through the pusher, it was noticed that the stent was deformed.The procedure was 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: 9670717
• Report Number: 3005099803-2020-00222
• Device Sequence Number: 379912
• 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,Followup
• Report Date (Section B): 04/16/2020

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 Model Number: M00537360
• Device Catalogue Number: 3736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/20/2020; 03/30/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/16/2020; 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1