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

Model Number	40495
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by mfr.: unit returned with its original box and together with a non-bsc catheter, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The guidewire returned together with its original opened pouch; besides, a non-bsc device was received.The device has the body kinked approximately at 7.5 cm, 49 cm, 77.5 cm and 123 cm from the proximal end.The guidewire distal tip was bent.The polymer distal tip was damaged.No more damages were found in the device.During the inspection, it was noted that the proximal end of the polymer tip was folded on itself; the folded section measured approximately 0.4 cm.The overall length of the device is within specification.The outer diameter of the distal tip, middle of the device, and proximal section are within specification.
Event or Problem Description
Reportable based on device analysis completed on 07may2020.It was reported that inserting difficulties were encountered.The 99% stenosed target lesion was located in the severely tortuous and mildly calcified forearm shunt.A 150cm, 8cm poly tip v-18 control wire guidewire was selected for use in combination with a non-bsc balloon catheter.However, the guidewire had difficulty inserting into the guidewire lumen of the balloon catheter.Both devices were removed and the procedure was completed with another of same device.No patient complications nor injuries were reported.However, returned device analysis revealed guidewire coating peeled/sheared.

• 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: 10052460
• Report Number: 2134265-2020-06368
• Device Sequence Number: 2782877
• 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
• Report Date (Section B): 05/13/2020

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 Expiration Date: 08/29/2021
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0024356010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1