MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00572270
Medical Device Problem Codes	Break (1069); Difficult or Delayed Positioning (1157); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2018
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).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an epic biliary endoscopic stent was implanted in the common bile duct during a stent placement procedure performed on (b)(6) 2018.According to the complainant, during deployment, the thumbwheel of the handle was being used; the stent was able to be released to an extent but then could not be fully released.A "slap" sound was heard and the distal part of the outer tube got separated.At this time the physician judged that the stent and delivery system could not be retrieved as it was, and the delivery system was cut with pliers where the handle meets the outer and inner tubes.The outer and inner tube were removed together with the endoscope.It was reported that after delivery system removal the stent was found to be placed in the originally planned location and the stent remained implanted to complete the procedure.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an epic biliary endoscopic stent was implanted in the common bile duct during a stent placement procedure performed on (b)(6) 2018.According to the complainant, during deployment, the thumbwheel of the handle was being used; the stent was able to be released to an extent but then could not be fully released.A "slap" sound was heard and the distal part of the outer tube got separated.At this time the physician judged that the stent and delivery system could not be retrieved as it was, and the delivery system was cut with pliers where the handle meets the outer and inner tubes.The outer and inner tube were removed together with the endoscope.It was reported that after delivery system removal the stent was found to be placed in the originally planned location and the stent remained implanted to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).An epic biliary delivery system was received for analysis; the stent was not returned.Visual examination of the returned delivery system found the blue outer sheath showed two separations.The first separation was located at 144 cm from the distal side of the marker band and the second separation was caused by the user cutting sheath at approximately 1 cm from the strain relief.The mid-sheath was also separated, where the user cut the device.The outer sheath also showed 1 kink located at 50cm from the distal end of the marker band.The inner shaft showed multiple kinks from the distal side of the marker band to the proximal side of the tip.No other issued with the device were noted.The damages noted to the delivery system were likely caused by procedural factors.Based on all gathered information, the investigation concluded that the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).An epic biliary delivery system was received for analysis; the stent was not returned.Visual examination of the returned delivery system found the blue outer sheath showed two separations.The first separation was located at 144 cm from the distal side of the marker band and the second separation was caused by the user cutting sheath at approximately 1 cm from the strain relief.The mid-sheath was also separated, where the user cut the device.The outer sheath also showed 1 kink located at 50cm from the distal end of the marker band.The inner shaft showed multiple kinks from the distal side of the marker band to the proximal side of the tip.No other issued with the device were noted.The damages noted to the delivery system were likely caused by procedural factors.Based on all gathered information, the investigation concluded that the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an epic biliary endoscopic stent was implanted in the common bile duct during a stent placement procedure performed on (b)(6) 2018.According to the complainant, during deployment, the thumbwheel of the handle was being used; the stent was able to be released to an extent but then could not be fully released.A "slap" sound was heard and the distal part of the outer tube got separated.At this time the physician judged that the stent and delivery system could not be retrieved as it was, and the delivery system was cut with pliers where the handle meets the outer and inner tubes.The outer and inner tube were removed together with the endoscope.It was reported that after delivery system removal the stent was found to be placed in the originally planned location and the stent remained implanted to complete the procedure.There were no patient complications as a result of this event.

• Brand Name: EPIC BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7960417
• Report Number: 3005099803-2018-60761
• Device Sequence Number: 1773462
• Product Code: FGE
• UDI-Device Identifier: 08714729896890
• UDI-Public: 08714729896890
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: 09/25/2019
• Device Model Number: M00572270
• Device Catalogue Number: 56705
• Device Lot Number: 0021174559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1