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

Model Number	M00572280
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
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).The device has been received for analysis; however 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an epic biliary stent was to be used to treat a malignant stricture that caused hepatic obstruction due to metastasis of the cancer cells in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed.However, resistance was felt when removing the delivery system from the stent and out from the common bile duct.It was noted that the delivery system was stuck/ jammed.The physician gave a sudden pull to the delivery system and as a result, the inner catheter was kinked and was detached inside the patient.The detached piece was removed with grasping forceps.The patient underwent a fluoroscopy and the images confirmed no broken piece was left inside the patient.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the condition of the procedure was reported to be fine.
Additional Manufacturer Narrative
An epic biliary delivery system was received for analysis; the stent was not returned.Visual examination of the returned device showed flattening damage and kink to the mid-sheath; the kink was located at 1.1 cm from the proximal end of the marker band, and the flattening damage was located at approximately 10 cm from the marker band.The inner shaft showed stretching and separation at 11 cm from the tip.No other issues with the device noted.The damage noted appeared to be consistent with stent interference.Due to tortuous anatomy, the device may have been caught in the stent after deployment.When the delivery system was removed, the inner shaft separated.The investigation concluded that the observed failures and the reported event are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A labeling review was performed, and from the information available, this device was used per the directions for use (dfu) / product label.A review of documentation 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 stent was to be used to treat a malignant stricture that caused hepatic obstruction due to metastasis of the cancer cells in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed.However, resistance was felt when removing the delivery system from the stent and out from the common bile duct.It was noted that the delivery system was stuck/ jammed.The physician gave a sudden pull to the delivery system and as a result, the inner catheter was kinked and was detached inside the patient.The detached piece was removed with grasping forceps.The patient underwent a fluoroscopy and the images confirmed no broken piece was left inside the patient.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the condition of the procedure was reported to be fine.

• Brand Name: EPIC
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7474130
• Report Number: 3005099803-2018-01333
• Device Sequence Number: 16448003
• Product Code: FGE
• UDI-Device Identifier: 08714729896906
• UDI-Public: 08714729896906
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

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: Health Professional
• Device Expiration Date: 11/10/2019
• Device Model Number: M00572280
• Device Lot Number: 21370259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/24/2018
• 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