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

Model Number	40495
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The more than 50% stenosed target lesion was located in the lower limb artery below the knee.After a 200cm, 8cm v-18 control wire was used to cross the lesion, a 3.0mm x 150mm x 90cm sterling sl balloon catheter was advanced for dilatation.Upon removal of the balloon, it was noted that the balloon not able to slide over the guidewire and the wire was stuck inside the balloon shaft.Both devices were pulled-out of the sheath as one unit.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned guidewire had the wire kinked and middle section.Additionally, the core wire exposed due to the polymer jacket peeled and kinked at distal tip.The distal tip was confirmed kinked and polymer peeled under microscope.The very tip is without detachment or exposed tip.The device was measured in three sections.The outer diameter of distal, medium and proximal were within specification.The peeled section related to polymer was measured and 1.9cm were missing.
Event or Problem Description
It was reported that removal difficulties were encountered.The more than 50% stenosed target lesion was located in the lower limb artery below the knee.After a 200cm, 8cm v-18 control wire was used to cross the lesion, a 3.0mm x 150mm x 90cm sterling sl balloon catheter was advanced for dilatation.Upon removal of the balloon, it was noted that the balloon not able to slide over the guidewire and the wire was stuck inside the balloon shaft.Both devices were pulled-out of the sheath as one unit.The procedure was completed with another of same device.No patient complications were reported and the patient 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: 12218597
• Report Number: 2134265-2021-09395
• Device Sequence Number: 3621316
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: 08714729070191
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K033742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2022
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0026526897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1