MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGWIRE REVOLUTION; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	M00557021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that the patient was transferred to this hospital for endoscopic retrograde cholangiopancreatography (ercp) with endoscopic ultrasonography (eus) guidance after unsuccessful ercp at an outside hospital.The procedure date is unknown.Patient underwent endoscopic retrograde cholangiopancreatography (ercp) with endoscopic ultrasonography (eus) guidance and laparoscopic cholecystectomy procedure and discharged on postoperative day four.It was reported the following devices were used in the procedure two jagwire revolution guidewires one.025 and one.035, another non-bsc guidewire, and a non-bsc single use 3 lumen sphincterotome.Post procedure, on (b)(6) 2022, two days after discharge, patient returned to the emergency room and ct scan showed a foreign body in the right upper quadrant consistent with piece of retained wire.The patient underwent diagnostic laparoscopy with exploratory laparotomy for removal of foreign body.Patient was discharged home two days later.
Additional Manufacturer Narrative
This event was reported to the fda via a voluntary medwatch report.The report number is 0501120000-2022-8009.(b)(4).

• Brand Name: JAGWIRE REVOLUTION
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• 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: 15801739
• Report Number: 3005099803-2022-06570
• Device Sequence Number: 5660311
• Product Code: OCY
• UDI-Device Identifier: 08714729934998
• UDI-Public: 08714729934998
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/15/2022

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 Model Number: M00557021
• Device Catalogue Number: 56480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown