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

Model Number	40495
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that foreign matter was present on the device.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified shunt vessel.A 200cm, 8cm poly tip v-18 control wire was selected for use together with a non-boston scientific (bsc) balloon catheter.However, a significant resistance was felt when the tip of the wire crossed the stent in front of the central lesion.An echocardiogram confirmed that it probably did not pass through the stent strut.It has been a while since the stent was placed, so the intima should be stretched.After the guide wire did not advance in the body and the torque was no longer effective, it was taken out of the body and the guide wire was advanced and pulled in the guide wire lumen of the balloon to check the condition, and a foreign object that was about 1 cm black that is thinner than the guide wire came out.According to the physician, the damage to the guidewire was not visually confirmed.The foreign matter seemed to be part of the guide wire.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that foreign matter was present on the device.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified shunt vessel.A 200cm, 8cm poly tip v-18 control wire was selected for use together with a non-boston scientific (bsc) balloon catheter.However, a significant resistance was felt when the tip of the wire crossed the stent in front of the central lesion.An echocardiogram confirmed that it probably did not pass through the stent strut.It has been a while since the stent was placed, so the intima should be stretched.After the guide wire did not advance in the body and the torque was no longer effective, it was taken out of the body and the guide wire was advanced and pulled in the guide wire lumen of the balloon to check the condition, and a foreign object that was about 1 cm black that is thinner than the guide wire came out.According to the physician, the damage to the guidewire was not visually confirmed.The foreign matter seemed to be part of the guide wire.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned, and it was observed the distal tip was bent.No more issues or damages were observed.The device outer diameter was dimensionally inspected and found to be within specification.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16308618
• Report Number: 2124215-2023-02696
• Device Sequence Number: 17840530
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: 08714729070191
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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: 02/16/2024
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0028884536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown