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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occured.The procedure was performed by venous approach.The 90% stenosed target lesion was located in a shunt in a severely tortuous and moderately calcified forearm vein.After a 150cm, 8cm v-18 control wire was advanced, pre-dilatation was performed with a peripheral cutting balloon.However, after inflation, resistance was encountered and the guidewire and balloon were then removed from the patient.When the guide wire was removed from the balloon, it was noticed that the coil part of the tip was separated.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.:the unit returned has wire tip detached, as part of overall visual revision.The wire was returned together with a non-bsci device.Visual inspection was performed.A section of the polymer tip (approximately 2.5 cm) was detached from the guidewire; the detached section was returned together with the device.The rest of the polymer tip attached to the guidewire did not show damages.The distal tip was kinked.The overall length, distal tip, middle of the device, and proximal section are within specification.No more damages were found in the returned device.Dimensional inspection was performed and the device was measured within specification.
Event or Problem Description
It was reported that tip detachment occured.The procedure was performed by venous approach.The 90% stenosed target lesion was located in a shunt in a severely tortuous and moderately calcified forearm vein.After a 150cm, 8cm v-18 control wire was advanced, pre-dilatation was performed with a peripheral cutting balloon.However, after inflation, resistance was encountered and the guidewire and balloon were then removed from the patient.When the guide wire was removed from the balloon, it was noticed that the coil part of the tip was separated.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 9030235
• Report Number: 2134265-2019-11163
• Device Sequence Number: 11365429
• Product Code: DQX
• UDI-Device Identifier: 08714729070184
• UDI-Public: 08714729070184
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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: 06/19/2021
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0023983067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER: PCB; BALLOON CATHETER: PCB; INTRODUCER SHEATH: MOSQUITO; INTRODUCER SHEATH: MOSQUITO