MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IDC; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83775
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	10/21/2019
Type of Reportable Event	Death
Event or Problem Description
It was reported that patient death occurred.The patient presented with a dissection in the left anterior descending (lad) artery.The patient was being treated with a 2mmx2cm idc coil.The coil was being delivered through a renegade catheter.The catheter was repositioned and the coil dislodged inside the lad.A snare was used to retrieve the dislodged coil.During the snaring of the coil, the patient became unstable.The physician continued coiling the patient with 3 additional idc coils that were successfully implanted in the septal.A synergy stent was then placed into the lad a few minutes after the embolization process.The patient coded.Cardiopulmonary resuscitation (cpr) was performed and echmo/ impella were used.Patient death occurred.No autopsy was performed.

• Brand Name: IDC
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9318250
• Report Number: 2134265-2019-13752
• Device Sequence Number: 1962028
• Product Code: KRD
• UDI-Device Identifier: 08714729158684
• UDI-Public: 08714729158684
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141378
• 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): 11/13/2019

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: 08/06/2021
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0022614844
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER - RENEGADE
• Outcome Attributed to Adverse Event: Death; Required Intervention