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

Model Number	2830
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip detachment occurred.The 100% stenosed target lesion was located in a saphenous vein graft (svg) in the non-tortuous and mildly calcified vessel.A 190cm straight-tip hornet 10 was selected for use.However, during angiography, it was noted that the tip was damaged and the radiopaque sleeve was separated from the tip.The wire was completely removed through the non-bsc microcatheter and the procedure was completed with a non-bsc guidewire.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.As a result of observing the appearance of the returned product, the coil winding was loosened and the pitch was opened from 10mm to 18mm from the tip.Along with this, a part of the coil protruded to the side, but there was no separation.In addition, a waviness over a length of 35mm and 1610mm from the distal tip was also observed.
Event or Problem Description
It was reported that the tip detachment occurred.The 100% stenosed target lesion was located in a saphenous vein graft (svg) in the non-tortuous and mildly calcified vessel.A 190cm straight-tip hornet 10 was selected for use.However, during angiography, it was noted that the tip was damaged and the radiopaque sleeve was separated from the tip.The wire was completely removed through the non-bsc microcatheter and the procedure was completed with a non-bsc guidewire.No patient complications nor injuries were reported.

• Brand Name: HORNET 10
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8929871
• Report Number: 2134265-2019-10178
• Device Sequence Number: 19319941
• Product Code: DQX
• UDI-Device Identifier: 08714729887690
• UDI-Public: 08714729887690
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K152231
• 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,Followup
• Report Date (Section B): 11/04/2019

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: 12/11/2021
• Device Model Number: 2830
• Device Catalogue Number: 2830
• Device Lot Number: 0023044886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 11/04/2019
• 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: MICROCATHETER: CORSAIR; MICROCATHETER: CORSAIR; MICROCATHETER: CORSAIR