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

Model Number	M00572300
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the stent remains implanted and will not be returned for evaluation; therefore, a problem 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
Note: this report pertains to a jagtome rx 44 and an epic biliary stent that were used in the same procedure.It was reported to boston scientific corporation on (b)(6) 2022 that a jagtome rx 44 and two epic biliary endoscopic stents were used to treat a malignant stricture in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with bilateral stenting procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, an epic biliary stent was successfully implanted over a non bsc guidewire.A second epic bliary stent was deployed over a jagwire guidewire.However, the jagwire guidewire was unable to be removed from the patient as it was stuck inside the deployed stent in the bile duct.The physician tried multiple attempts to remove the guidewire endoscopically with rat tooth forceps, biopsy forceps, and a hurricane rx to dilate the bile duct.However, all attempts were unsuccessful.The guidewire remained stuck and was coming out of the patient's mouth so the patient remained in the hospital and was referred to a surgeon.An open surgery was performed and the guidewire was cut in the duodenum.The surgeon manually pushed the guidewire up into the liver which then dislodged the guidewire from the epic stent.The guidewire was then pulled to remove it from the bile duct and patient.The stent remains implanted.The patient's condition at the conclusion of the surgery was reported to be good.
Event or Problem Description
Note: this report pertains to a jagtome rx 44 and an epic biliary stent that were used in the same procedure.It was reported to boston scientific corporation on (b)(6) 2022 that a jagtome rx 44 and two epic biliary endoscopic stents were used to treat a malignant stricture in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with bilateral stenting procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, an epic biliary stent was successfully implanted over a non bsc guidewire.A second epic bliary stent was deployed over a jagwire guidewire.However, the jagwire guidewire was unable to be removed from the patient as it was stuck inside the deployed stent in the bile duct.The physician tried multiple attempts to remove the guidewire endoscopically with rat tooth forceps, biopsy forceps, and a hurricane rx to dilate the bile duct.However, all attempts were unsuccessful.The guidewire remained stuck and was coming out of the patient's mouth so the patient remained in the hospital and was referred to a surgeon.An open surgery was performed and the guidewire was cut in the duodenum.The surgeon manually pushed the guidewire up into the liver which then dislodged the guidewire from the epic stent.The guidewire was then pulled to remove it from the bile duct and patient.The stent remains implanted.The patient's condition at the conclusion of the surgery was reported to be good.
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the stent remains implanted and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 13544231
• Report Number: 3005099803-2022-00691
• Device Sequence Number: 17412090
• Product Code: FGE
• UDI-Device Identifier: 08714729896920
• UDI-Public: 08714729896920
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2023
• Device Model Number: M00572300
• Device Catalogue Number: 7230
• Device Lot Number: 0028378137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown