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

Device Problem Difficult to Advance (2920)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

Note: this report is two of two complaints that pertain to the same event (mfr report # 3005099803-2022-07652).It was reported to boston scientific corporation that a flexima biliary stent and a jagwire was used during an endoscopic retrograde cholangiopancreatography (erc), biopsy, and plastic biliary stent placement procedure in the biliary, performed on (b)(6) 2022.During the procedure, upon deployment of the stent, when the guide catheter was pulled, the stent would not detach from the guide catheter and failed to deploy.It was noticed that the distal part of the guide catheter started to elongate and had to be cut with a wire cutter.The jagwire guidewire was also stuck.The procedure was not completed due to this event.It was reported that the patient was transferred to a different facility, incan (national cancer institute, and it was unknown if there was an intervention nor if there was a plan for reschedule to complete the procedure.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the guide catheter was stretched and kinked.

Manufacturer Narrative

(b)(4).

• 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 CORPORATION; 780 brookside drive; spencer 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16045489
• MDR Text Key: 306455205
• Report Number: 3005099803-2022-07557
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/23/2022
• 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 Age: 59 YR
• Patient Sex: Female