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

Model Number 40456

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/05/2018

Event Type  Injury  

Event Description

It was reported that the guidewire tip detached and remained in the patient.A v-14 control wire was selected for use for a percutaneous transluminal angioplasty (pta) procedure in the left distal fibularis to treat chronic total occlusion.The target lesion was not tortuous, however, the lesion was highly calcified and 100% stenosed.The physician attempted to recanalize the total occlusion.When the physician attempted to remove the wire, resistance was felt and the wire made a loop in the occluded segment of the lesion, and the wire tip became stuck.The physician attempted to pull the wire and 1-2 cm of the wire tip detached.The tip was detached in the area of total occlusion, so no attempts to retrieve the wire were made.The physician believes the tip detached due to the patient's underlying condition and anatomy characteristics, and there is no further intervention planned to retrieve the device fragment.There were no further patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: investigation completed on returned device.Visual analysis revealed that the distal tip had a kink, and the distal coating of the wire was peeled off and missing.The core wire was not broken and remained in tact.There was no other damage or irregularities observed.

Event Description

It was reported that the guidewire tip detached and remained in the patient.A v-14 control wire was selected for use for a percutaneous transluminal angioplasty (pta) procedure in the left distal fibularis to treat chronic total occlusion.The target lesion was not tortuous, however, the lesion was highly calcified and 100% stenosed.The physician attempted to recanalize the total occlusion.When the physician attempted to remove the wire, resistance was felt and the wire made a loop in the occluded segment of the lesion, and the wire tip became stuck.The physician attempted to pull the wire and 1-2cm of the wire tip detached.The tip was detached in the area of total occlusion, so no attempts to retrieve the wire were made.The physician believes the tip detached due to the patient's underlying condition and anatomy characteristics, and there is no further intervention planned to retrieve the device fragment.There were no further patient complications reported.

• Brand Name: V-14 CONTROL WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8169720
• MDR Text Key: 130508984
• Report Number: 2134265-2018-63923
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: 08714729799221
• Combination Product (y/n): N
• PMA/PMN Number: K112745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2020
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0022529032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other