MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00573550

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2022

Event Type  Injury  

Event 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 stent were used to treat a malignant stricture in the bile duct during a bilateral endoscopic retrograde cholangiopancreatography (ercp) 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 bilary 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.

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed 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: JAGTOME RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13543567
• MDR Text Key: 285694889
• Report Number: 3005099803-2022-00644
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: M00573550
• Device Catalogue Number: 7355
• Device Lot Number: 0028438937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention