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

Model Number	40495
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guide wire detachment occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the vessel in the abdomen.A 150cm, 8cm v-18 control wire was advanced to cross the lesion.However, when trying to access a 22x20cm needle, the wire broke off.Another 150cm, 8cm v-18 control wire was advanced but the wire also broke off.No patient complications were reported and the patient status was okay.
Additional Manufacturer Narrative
Updated: b1 - updated from product problem to adverse event and product problem.H1 - updated from malfunction to serious injury.Device evaluated by mfr.: the unit returned with its original pouch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The distal tip of the device has the polymer tip peeled in some sections and the detached sections were not returned; some sections of the core wire were exposed.The distal tip was kinked.No more damages were found in the returned device.It was inspected according to procedure.Outer diameter of distal tip could not be performed due to device condition.Outer diameter of the middle of the device and the proximal section are within specifications.The device was measured according to the drawing.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that guide wire detachment occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the vessel in the abdomen.A 150cm, 8cm v-18 control wire was advanced to cross the lesion.However, when trying to access a 22x20cm needle, the wire broke off.Another 150cm, 8cm v-18 control wire was advanced but the wire also broke off.No patient complications were reported and the patient status was okay.It was further reported that the detached fragment was not retrieved.

• 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: 8716194
• Report Number: 2134265-2019-07182
• Device Sequence Number: 2387152
• Product Code: DQX
• UDI-Device Identifier: 08714729070184
• UDI-Public: 08714729070184
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/05/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2021
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0023174797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 08/05/2019
• 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: Other