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

Model Number	2831
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Used (b)(6) 2018 as event date since the correct date was not provided.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the calcified left anterior descending artery.A 190cm straight tip hornet 14 guidewire was advanced but failed to cross the lesion and the tip got fractured.No fragment was left inside the patient's body.A spring coil brought the remaining portion of the wire back together.The procedure was completed with a non bsc device.No patient serious injury or adverse event were reported and the patient's status was good.
Additional Manufacturer Narrative
Used (b)(6) 2018 as event date since the correct date was not provided.Device evaluated by mfr.: the device was returned for analysis.It was confirmed that the core was severed at a position about 6mm from the tip and the coil was stretched in the distal direction.It was confirmed that the core fragment was enclosed by the stretched distal coil tip and it was confirmed that no part of the core was missing.In addition, although it was confirmed that the distal 130mm was gently curved, no other abnormalities could be confirmed.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the calcified left anterior descending artery.A 190cm straight tip hornet 14 guidewire was advanced but failed to cross the lesion and the tip got fractured.No fragment was left inside the patient's body.A spring coil brought the remaining portion of the wire back together.The procedure was completed with a non bsc device.No patient serious injury or adverse event were reported and the patient's status was good.

• 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: 8156534
• Report Number: 2134265-2018-63878
• Device Sequence Number: 16551805
• Product Code: DQX
• UDI-Device Identifier: 08714729887751
• UDI-Public: 08714729887751
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: 04/08/2021
• Device Model Number: 2831
• Device Catalogue Number: 2831
• Device Lot Number: 0021919201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 02/21/2019
• 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