MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40535
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	02/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that distal tip detachment occurred.The 90% to 100% stenosed target lesion were located in the mildly tortuous common iliac, external iliac and common femoral vein.A 300cm, 12cm poly tip v-18 control wire was advanced to cross the occlusion.However, it was noted that the tip of the wire got stuck in the occlusion and the back part buckled.When the wire was pulled back, it was noticed that the tip had broken off.A snare was advanced towards the broken off tip but couldn't get the detached fragment.Multiple attempts were made to cross the occlusion but failed, so the procedure was stopped.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device manufacture date: updated to 11/24/2018.Device evaluated by mfr: the unit was returned in a generic plastic bag.Analysis of returned product revealed that the device has it middle section kink.The device was broken on 297.7 cm from proximal section to broken section, overall length should be 300 cm.Additionally, the distal tip was detached; consequently, confirming the reported complaint.
Event or Problem Description
It was reported that distal tip detachment occurred.The 90% to 100% stenosed target lesion were located in the mildly tortuous common iliac, external iliac and common femoral vein.A 300cm, 12cm poly tip v-18 control wire was advanced to cross the occlusion.However, it was noted that the tip of the wire got stuck in the occlusion and the back part buckled.When the wire was pulled back, it was noticed that the tip had broken off.A snare was advanced towards the broken off tip but couldn't get the detached fragment.Multiple attempts were made to cross the occlusion but failed, so the procedure was stopped.There were no patient complications reported and the patient's status was stable.

• Brand Name: V-18 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8336438
• Report Number: 2134265-2019-01157
• Device Sequence Number: 2285428
• Product Code: DQX
• UDI-Device Identifier: 08714729070238
• UDI-Public: 08714729070238
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033742
• 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): 04/25/2019

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: 11/23/2020
• Device Model Number: 40535
• Device Catalogue Number: 40535
• Device Lot Number: 22982690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 04/25/2019
• 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