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

Model Number	H749393071900
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire tip detached and was unretrieved, requiring additional intervention.The patient presented with a chronic total occlusion (cto) of the circumflex artery.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified circumflex artery.A 190cm straight tip pouch hornet 14 guidewire was selected for use.However, during the procedure, the wire tip became stuck in the calcified lesion and with further manipulation, the tip of the wire broke off and remained in the patient.The rest of the wire was removed successfully.The decision was made to not retrieve the detached guidewire to prevent further injury.The intended stent was placed and additionally stabilized the wire tip fragment to the vessel wall with stent placement.The procedure was completed and the patient was fully recovered.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.
Event or Problem Description
It was reported that the guidewire tip detached and was unretrieved, requiring additional intervention.The patient presented with a chronic total occlusion (cto) of the circumflex artery.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified circumflex artery.A 190cm straight tip pouch hornet 14 guidewire was selected for use.However, during the procedure, the wire tip became stuck in the calcified lesion and with further manipulation, the tip of the wire broke off and remained in the patient.The rest of the wire was removed successfully.The decision was made to not retrieve the detached guidewire to prevent further injury.The intended stent was placed and additionally stabilized the wire tip fragment to the vessel wall with stent placement.The procedure was completed and the patient was fully recovered.

• Brand Name: HORNET 14
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18221906
• Report Number: 2124215-2023-64440
• Device Sequence Number: 12449639
• Product Code: DQX
• UDI-Device Identifier: 08714729887751
• UDI-Public: (01)08714729887751(17)260702(10)31941901
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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: 07/02/2026
• Device Model Number: H749393071900
• Device Catalogue Number: 2831
• Device Lot Number: 0031941901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: White