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

Model Number	M00534230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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¿ rx preloaded biliary stent was removed from a patient during a planned stent removal procedure performed in common bile duct on (b)(6) 2016.On (b)(6) 2016 the advanix biliary stent was implanted in the patient for 8 weeks to heal a bile leak.No issues were reported with the device during implantation.According to the complainant, on (b)(6) 2016, during the stent removal procedure, the stent was identified in the duodenum and was grasped above the distal flange with rat tooth forceps.As the physician attempted to pull the stent from duct, the stent stretched and ripped.A snare was used to very slowly and gradually remove the damaged stent from the duct.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 "stable".
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the stent was broken.The stent had some blackened areas, also it was necked, flattened and kinked in some locations, the barb in the distal section of the stent was kinked and the most proximal section of the stent was stretched.Probably the stent was blackened due to the device was in place for several weeks.The dfu indicates the following in stent removal section: "the advanix biliary stent can be removed via standard stent removal techniques by a trained physician in endoscopic biliary procedures.".Per complaint information the customer used a rat tooth forcep to remove the stent and the stent broke off, then the customer decided to use an snare to remove the stent.Using snare is a standard biliary stent removal technique.The damages found on the stent are typically made due to grab and pull the stent with the snare during the stent removal.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.Search of the complaint database revealed that no similar complaints exist for the specified lot.A labeling review was performed no anomaly was found.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx preloaded biliary stent was removed from a patient during a planned stent removal procedure performed in common bile duct on (b)(6) 2016.On (b)(6) 2016 the advanix biliary stent was implanted in the patient for 8 weeks to heal a bile leak.No issues were reported with the device during implantation.According to the complainant, on (b)(6) 2016, during the stent removal procedure, the stent was identified in the duodenum and was grasped above the distal flange with rat tooth forceps.As the physician attempted to pull the stent from duct, the stent stretched and ripped.A snare was used to very slowly and gradually remove the damaged stent from the duct.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 "stable".

• Brand Name: ADVANIX¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6217979
• Report Number: 3005099803-2016-03978
• Device Sequence Number: 16259506
• Product Code: FGE
• UDI-Device Identifier: 08714729787327
• UDI-Public: (01)08714729787327(17)20180531(10)19262351
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: M00534230
• Device Catalogue Number: 3423
• Device Lot Number: 19262351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 01/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention