MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FIGHTER; CATHETER, GUIDEWIRE

Model Number	2837
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Stroke/CVA (1770); Embolism (1829); Numbness (2415); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire distal tip detachment occured.The target lesion was located in the circumflex.A 190cm fighter was advanced to treat the lesion.The device was crossed through the totally occluded lesion and embedded in the calcium.When the turnpike was advanced over the wire for exchange, they the pulled the wire back and 4 cm of the tip broke off.The wire remained in the patient's body.No patient complication were reported.The next day, a new wire was placed next the detached component and a stent was deployed to trap the wire.The procedure was successful without any issue to the patient.
Event or Problem Description
It was reported that guidewire distal tip detachment occured.The target lesion was located in the circumflex.A 190cm fighter was advanced to treat the lesion.The device was crossed through the totally occluded lesion and embedded in the calcium.When the turnpike was advanced over the wire for exchange, they the pulled the wire back and 4 cm of the tip broke off.The wire remained in the patient's body.No patient complication were reported.The next day, a new wire was placed next the detached component and a stent was deployed to trap the wire.The procedure was successful without any issue to the patient.It was further reported that the device was lodged in the distal circmflex and they could never get back to it through antegrade approach.They went to retrograde and externalized the wire and attempted the circumflex trapping the wire.
Event or Problem Description
It was reported that guidewire distal tip detachment occured.The target lesion was located in the circumflex.A 190cm fighter was advanced to treat the lesion.The device was crossed through the totally occluded lesion and embedded in the calcium.When the turnpike was advanced over the wire for exchange, they the pulled the wire back and 4 cm of the tip broke off.The wire remained in the patient's body.No patient complication were reported.The next day, a new wire was placed next the detached component and a stent was deployed to trap the wire.The procedure was successful without any issue to the patient.It was further reported that the device was lodged in the distal circumflex and they could never get back to it through antegrade approach.They went to retrograde and externalized the wire and attempted the circumflex trapping the wire.It was further reported that the saphenous vein graft was occluded.The native obtuse marginal (om) was wired and ballooned proximally.The distal wire tip detached in the distal vessel.Three or four days after the initial procedure, the patient presented with left facial numbness and arm numbness.The patient was monitored overnight and the following day underwent a brain mri which revealed scattered punctate acute infarcts in the bilateral cerebral and left cerebellar hemispheres.On (b)(6) 2019, the patient exhibited small embolic stroke pattern likely related to the catheterization procedure versus a cardioembolic source.

• Brand Name: FIGHTER
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8327836
• Report Number: 2134265-2019-01054
• Device Sequence Number: 1788858
• Product Code: DQX
• UDI-Device Identifier: 08714729886617
• UDI-Public: 08714729886617
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K151840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2021

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: 01/10/2021
• Device Model Number: 2837
• Device Catalogue Number: 2837
• Device Lot Number: 0021589650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/05/2019; 12/21/2020
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/25/2019; 01/14/2021
• 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: 52 YR