MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DREAMWIRE; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M00556141
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
This report pertains to a dreamwire manufacturer report# jagwire revolution 3005099803-2020-05391 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: DREAMWIRE
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10842738
• Report Number: 3005099803-2020-05234
• Device Sequence Number: 14487051
• Product Code: EZB
• UDI-Device Identifier: 08714729777885
• UDI-Public: 08714729777885
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: M00556141
• Device Catalogue Number: 5614
• Device Lot Number: 0025527325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1