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

Model Number	2749
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via facility medwatch# mw5094849 that tip detachment and perforation occurred.The 70-80% stenosed target lesion was located in the heavily calcified ramus branch.A 300cm j luge guidewire was used to cross the lesion along with another wire.Cutting balloons and non-compliant balloon catheters were used for dilatation.However, upon wire removal, the distal tip of the wire broke off and perforation was noted.Subsequently, emergency echocardiogram was performed which revealed no pericardial effusion.The detached fragment was left in place and no further patient complications were reported.The patient was hemodynamically stable and was discharged the following day.

• 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: 10224563
• Report Number: 2134265-2020-08797
• Device Sequence Number: 14251768
• Product Code: DQX
• UDI-Device Identifier: 08714729252214
• UDI-Public: 08714729252214
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• 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): 07/02/2020

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: 01/14/2022
• Device Model Number: 2749
• Device Catalogue Number: 2749
• Device Lot Number: 0025050691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/02/2020
• 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: Other