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

Model Number	2833
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that tip detachment and vessel dissection occurred.A 190cm, straight-tip hornet guidewire was inserted to the target lesion located in the mid left anterior descending artery.However, during procedure the wire broke off and it remained in the target lesion and caused vessel dissection.The procedure was completed with a non bsc device.No further patient complications were reported.
Event or Problem Description
It was reported that tip detachment and vessel dissection occurred.A 190cm, straight-tip hornet guidewire was inserted to the target lesion located in the mid left anterior descending artery.However, during procedure the wire broke off and it remained in the target lesion and caused vessel dissection.The procedure was completed with a non bsc device.No further patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr.: the device was returned for analysis.It was confirmed that part of the distal end is missing and the wire is kinked.Specifically, the core was severed at a position about 8mm from the tip and at a position 13mm from the tip.The coil was stretched in the direction of the tip and severed.The length of the missing core wire is approximately 8mm and the length of the missing coil is estimated to be at most about 13mm.Also, there were two kinks observed; one 50mm from the distal tip with the wire bent at 50 degrees and the other 825mm from the distal tip with the wire bent at 85 degrees.

• Brand Name: HORNET
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8125278
• Report Number: 2134265-2018-63452
• Device Sequence Number: 19414404
• Product Code: DQX
• UDI-Device Identifier: 08714729887713
• UDI-Public: 08714729887713
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 02/05/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2020
• Device Model Number: 2833
• Device Catalogue Number: 2833
• Device Lot Number: 0020901720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 02/05/2019
• 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