MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HORNET 10; CATHETER, GUIDEWIRE

Model Number	2835
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	08/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the moderate to severely calcified left anterior descending artery.A 190cm, straight-tip hornet 10 guidewire was selected for use.However, during unpacking, the tip of the guidewire broke.The procedure was completed with another of same device.No patient complications nor injuries were reported and the patient status was stable.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the moderate to severely calcified left anterior descending artery.A 190cm, straight-tip hornet 10 guidewire was selected for use.However, during unpacking, the tip of the guidewire broke.The procedure was completed with another of same device.No patient complications nor injuries were reported and the patient status was stable.
Additional Manufacturer Narrative
The device was returned for analysis.A kink was observed with an inner angle of about 166 degrees 1260mm from the distal tip.No other abnormalities were observed.

• Brand Name: HORNET 10
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15530260
• Report Number: 2124215-2022-38836
• Device Sequence Number: 17656366
• Product Code: DQX
• UDI-Device Identifier: 08714729886631
• UDI-Public: 08714729886631
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2022
• Device Model Number: 2835
• Device Catalogue Number: 2835
• Device Lot Number: 0024876465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 61 KG