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

Model Number UNK-P-JAGWIRE_REVOLUTION

Device Problems Peeled/Delaminated (1454); Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.(b)(4).

Event Description

Note: this report pertains to a dreamwire manufacturer report# 3005099803-2020-05234 and jagwire revolution used during the same procedure.It was reported to boston scientific corporation that a jagwire revolution and a dreamwire guidewire were used in the common bile duct during an endoscopic ultrasound (eus) guided rendezvous procedure on (b)(6) 2020.According to the complainant, during the procedure, a non boston scientific eus needle went through the stomach and gained access into the intrahepatic ducts.A dreamwire was used however no issues were reported with this guidewire.When trying to advance the jagwire revolution into the common bile duct to exit the ampulla the ptfe portion of the jagwire revolution detached in the left duct.The procedure was cancelled since access was lost while cannulating.Reportedly, patient went to ir (interventional radiology), but it was not primarily to remove the portion that detached but rather to perform percutaneous transhepatic cholangiography (ptc).The ifu for dreamwire and jagwire revolution states the following: do not use with metal-tip catheters.Withdrawing the guidewire through a metal tip catheter may damage the surface of the guidewire.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: JAGWIRE REVOLUTION
• 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 ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10842946
• MDR Text Key: 226167365
• Report Number: 3005099803-2020-05391
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2020

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
• Device Model Number: UNK-P-JAGWIRE_REVOLUTION
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/16/2020
• 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