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

Model Number	M00572300
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2021 that an epic biliary endoscopic stent was to be implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6), 2021.During the procedure, the stent was partially deployed.The procedure was completed with another epic biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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), 2021 that an epic biliary endoscopic stent was to be implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6), 2021.During the procedure, the stent was partially deployed.The procedure was completed with another epic biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block h6: medical device problem code a15 captures the reportable event of stent partially deployed.Block h10: an epic biliary endoscopic delivery system was received for analysis; the stent was not returned.Visual examination found that the stent was deployed off from the delivery system.The inner sheath was kinked at 1.6cm and 2.4cm from the tip.The lock on the rack was missing and the sheath was no longer sitting on top of the proximal end of the tip.No other issues with the delivery system were noted.The reported event of stent partially deployed could not be confirmed as the stent was not returned.Furthermore, there were no kinks noted on the sheath to line up with the kinks noted on the inner sheath.It is most likely that the kinked inner sheath occurred after the stent was partially deployed.Additionally, the lock was no longer on the rack and the sheath was no longer in the manufactured position.Per epic instructions for use (ifu), "premature removal of the safety lock may result in an unintended deployment of the stent." it is likely that the user failed to follow the instructions in the ifu which could have led to the partially deployed stent.Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instructions.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 on december 16, 2021 that an epic biliary endoscopic stent was to be implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2021.During the procedure, the stent was partially deployed.The procedure was completed with another epic biliary stent.There were no patient complications reported 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13193830
• Report Number: 3005099803-2021-08197
• Device Sequence Number: 19912361
• Product Code: FGE
• UDI-Device Identifier: 08714729896920
• UDI-Public: 08714729896920
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 07/21/2023
• Device Model Number: M00572300
• Device Catalogue Number: 7230
• Device Lot Number: 0027703659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown