MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUGE; WIRE, GUIDE, CATHETER

Model Number	2747
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery at 270 degrees.A 182cm luge guidewire was selected to insert in the lesion.However, during removal of the wire at the end of the case, the tip was separated from the wire.The physician delivered the stent with another luge wire and tacked the tip up along the vessel wall and the procedure completed.There were no patient complications reported.
Event or Problem Description
It was reported that tip detachment occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery at 270 degrees.A 182cm luge guidewire was selected to insert in the lesion.However, during removal of the wire at the end of the case, the tip was separated from the wire.The physician delivered the stent with another luge wire and tacked the tip up along the vessel wall and the procedure completed.There were no patient complications reported.
Additional Manufacturer Narrative
Media inspection: customer attached 5 pictures related to this procedure, three of them is showing the detachment of the distal tip of the guidewire within the patient and pictures number 4 and 5 are showing part of the front label of the pouch of the guidewire involved in this complaint.H3 other text : media review.

• Brand Name: LUGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11314670
• Report Number: 2134265-2021-01520
• Device Sequence Number: 11441359
• Product Code: DQX
• UDI-Device Identifier: 08714729877080
• UDI-Public: 08714729877080
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2022
• Device Model Number: 2747
• Device Catalogue Number: 2747
• Device Lot Number: 0026227264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR