MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-14 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40458
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the wire detached inside the patient.A 300cm v-14 control wire was selected for use for below-the-knee (btk) procedure of the heavily calcified lesion.During the procedure, the distal end of the wire tip detached inside the patient.The wire fragment remained in the patient's leg.There were no further patient complications and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of a 300cm v-14 control wire.Visual inspection of the returned guidewire showed a section of the polymer tip was detached.The damaged section was located approximately at 298.8 cm from the proximal end.The detached section of the device was not returned.The distal tip was kinked as well as the body; the body was kinked approximately at 172 cm from the proximal end.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the tip of the wire detached inside the patient.A 300cm v-14 control wire was selected for use for below-the-knee (btk) procedure of the heavily calcified lesion.During the procedure, the distal end of the wire tip detached inside the patient.The wire fragment remained in the patient's leg.There were no further patient complications and the patient was stable post procedure.

• Brand Name: V-14 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9473710
• Report Number: 2134265-2019-15791
• Device Sequence Number: 14130163
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: 08714729799269
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

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: 02/09/2021
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0023323869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/04/2020
• 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: Other