MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HORNET 14; CATHETER, GUIDEWIRE

Model Number	2831
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Pericardial Effusion (3271)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel perforation occurred which led to pericardial effusion requiring additional intervention.The 100% stenosed target lesion was located in the moderately calcified left anterior descending artery.A 190cm straight tip hornet 14 guidewire was attempted to cross the lesion.The 190cm straight tip hornet 14 guidewire then perforated the vessel.Pericardial effusion was observed and was treated with pericardiocentesis.The procedure was aborted due to the perforation and it is planned to reschedule the treatment for a later date.No further patient complications were reported and the patient was stable.

• Brand Name: HORNET 14
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11255362
• Report Number: 2134265-2021-00922
• Device Sequence Number: 11562801
• Product Code: DQX
• UDI-Device Identifier: 08714729887751
• UDI-Public: 08714729887751
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K151840
• 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
• Report Date (Section B): 01/29/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2023
• Device Model Number: 2831
• Device Catalogue Number: 2831
• Device Lot Number: 0024996452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/29/2021
• 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: Other; Required Intervention