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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 08/15/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation on august 18, 2022 that an unknown jagwire was used with a wallflex enteral colonic stent (the subject of manufacturer report # 3005099803-2022-05145) to treat a malignant stricture in the sigmoid colon during a colonoscopy procedure performed on (b)(6), 2022.The patient's anatomy was not tortuous.During the procedure, a scope was initially placed then the jagwire guidewire was put through and was advanced to the obstruction.The wallflex enteral colonic stent was put over the jagwire and pushed through the obstruction along with the scope.The physician then removed the scope and attempted to deploy the stent with 100% fluoroscopy.Post procedure, the patient abdomen looked distended.Colonoscopy was performed and perforation was noted above the stricture.Surgery was done on the same day to close the perforation.The patient was fully recovered at the end of the procedure.Note: in the physician's assessment, the jagwire could not be ruled out as possibly related to the perforation but also that the perforation was likely related poor visualization of the stricture as the wallflex stent was advanced to the stricture over the jagwire without endoscope visualization.

• Brand Name: JAGWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15438421
• MDR Text Key: 300050025
• Report Number: 3005099803-2022-05376
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention