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 08/04/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that jagwire was used during a procedure performed on (b)(6) 2022.During the procedure, after two back and forth passages of the guidewire in the dreamtome to go up in the papilla, it was impossible to advance the guidewire.It stops just before the tip at the level of the blue part.On the 3rd model, 0.025 jagwire was used.No problem was observed however catheterization failed in the papilla.The biliary catheterization could not be made, thus, procedure was not completed due to this event.There is an increase of anesthetic time for the patient and was on pse noradrenaline.The patient was then transferred to the nearest health facility.

Manufacturer Narrative

(b)(4).The complainant indicated that the device 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.

Manufacturer Narrative

(impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.The complainant indicated that the device 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.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.

Event Description

Note: this report pertains to the jagwire guidewire and two dreamtome rx 44 and used during the same procedure.It was reported to boston scientific corporation that two dreamtome rx 44 and a jagwire guidewire were used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, upon cannulation into the papilla, there was difficulty advancing the guidewire through the tome.A second dreamtome rx 44 was used; however, the same problem happened.It seemed like the guidewire channel of the tome was blocked and it was impossible for the guidewire to advance as it stopped at the level of the blue part just before the tip.The devices were tried outside the patient but the same problem occurred.They also tried rinsing with saline; however, the same problem happened.A third dreamtome rx 44 was used wherein a jagwire guidewire was inserted; however, it did not adapt to the situation as it was unable to cannulate into the papilla.The procedure was not completed due to this event.Since biliary catheterization could not be made, the patient was transferred to the nearest facility.There were no patient complications reported as a result of this event.

• 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; 2546 calle primera; alajuela 47460 ; CS 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15254462
• MDR Text Key: 305368561
• Report Number: 3005099803-2022-04709
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

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?: No
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/30/2022
• 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