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); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a coating issue occurred.A v-18 200cm, 8cm control wire was selected for use.During the procedure, the wire had become increasingly difficult to advance.The wire was pulled out observed that the entire eight centimeters of the wire coating was off.All of the wire coating was able to be removed from the patient, and a new v-18 control wire was used and completed the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: this v-18 200cm, 8cm control wire was returned for analysis.Visual inspection observed that the guidewire was bent at the distal tip section and the polymer jacket was detached.The coating issue observed in the field was confirmed through analysis.Historical review of this failure indicates potential factors such as excessive handling of the device, the technique used by the physician, and normal procedural difficulties encountered during the procedure that could have possibly affected the device performance and its integrity.
Event or Problem Description
It was reported that coating issue occurred.A v-18 200cm, 8cm control wire was selected for use.During the procedure, the wire had become increasingly difficult to advance.The wire was pulled out observed that the entire 8 centimeters of the wire coating was off.All of the wire coating was able to be removed from the patient, and a new v-18 control wire was used and completed the procedure.No patient complications were reported.

• Brand Name: V-18 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17843193
• Report Number: 2124215-2023-53690
• Device Sequence Number: 7247516
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: 08714729070191
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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: 05/23/2025
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0031682985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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