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

Model Number	M00556161
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that three dreamwires were used during an endoscopic ultrasound hepaticogastrostomy procedure performed on (b)(6) 2022.During the procedure, the guidewire was advanced through a 19ga expect eus needle to gain access into the desired duct.While manipulating the guidewire, the hydrophilic coating was scathed off by the end of the eus needle.Three dreamwires were used and the same problem occurred.The procedure was not completed due to not being able to gain correct access of intrahepatic ducts and was referred to interventional radiology.Per the dreamwire ifu (50693808 rev b) there is "caution: do not use with metal-tip catheters.Withdrawing the guidewire through a metal tip catheter may damage the surface of the guidewire." there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: one dreamwire guidewire was returned.A visual inspection revealed, the distal tip was peeled and detached.The reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed for the user error of the distal tip detachment, was probably caused by the guidewire advancing through a 19ga expect eus needle.Boston scientific has determined the most probable cause of this complaint is failure to follow instructions.Since the problem is traced to the user not following the manufacturer's instructions.
Event or Problem Description
It was reported to boston scientific corporation that three dreamwires were used during an endoscopic ultrasound hepaticogastrostomy procedure performed on (b)(6)2022.During the procedure, the guidewire was advanced through a 19ga expect eus needle to gain access into the desired duct.While manipulating the guidewire, the hydrophilic coating was scathed off by the end of the eus needle.Three dreamwires were used and the same problem occurred.The procedure was not completed due to not being able to gain correct access of intrahepatic ducts and was referred to interventional radiology.There were no patient complications reported as a result of this event.Per the dreamwire ifu (50693808 rev b) there is "caution: do not use with metal-tip catheters.Withdrawing the guidewire through a metal tip catheter may damage the surface of the guidewire.".

• Brand Name: DREAMWIRE
• Common Device Name: STYLET FOR CATHETER, GASTRO-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: 15229440
• Report Number: 3005099803-2022-04566
• Device Sequence Number: 4652005
• Product Code: EZB
• UDI-Device Identifier: 08714729777861
• UDI-Public: 08714729777861
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2025
• Device Model Number: M00556161
• Device Catalogue Number: 5616
• Device Lot Number: 0029401549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 63 KG