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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION JAGTOME RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
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.
 
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Brand NameJAGTOME RX 44
Type of DeviceUNIT, 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 Key13543567
MDR Text Key285694889
Report Number3005099803-2022-00644
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00573550
Device Catalogue Number7355
Device Lot Number0028438937
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/16/2022 Patient Sequence Number: 1
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