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

Model Number	40495
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire coating was peeled off.The target lesion was located in the superficial femoral artery.A150cm, 8cm v-18 control wire was used in a procedure.The balloon and the wire were removed from the patient's body.However, when the wire was removed from the balloon catheter outside the patient's body, the hydrophilic coating was noted to be peeled off.No patient complications were reported.
Event or Problem Description
It was reported that the wire coating was peeled off.The target lesion was located in the superficial femoral artery.A150cm, 8cm v-18 control wire was used in a procedure.The balloon and the wire were removed from the patient's body.However, when the wire was removed from the balloon catheter outside the patient's body, the hydrophilic coating was noted to be peeled off.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: inside of a petri dish a transparent strip was received which matches with the hydrophilic coating of the device.The guidewire was not returned.

• 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: 9354094
• Report Number: 2134265-2019-14111
• Device Sequence Number: 19372697
• Product Code: DQX
• UDI-Device Identifier: 08714729070184
• UDI-Public: 08714729070184
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

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 Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0024148138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1