MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-14 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	H74939216930010
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coating issue occurred.The v-14 control guidewire long taper 300cm straight tip was used for during treatment of peripheral artery disease, however, during an angiogram the wire coating peeled at the distal tip.It was confirmed no coating/wire fragments were left inside the patient, and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Media/product analysis: the complaint device was not returned by the customer; nevertheless, physician has provided a photo of the device.As per the photo provided, the distal tip was found kinked and peeled.
Event or Problem Description
It was reported that coating issue occurred.The v-14 control guidewire long taper 300cm straight tip was used for during treatment of peripheral artery disease, however, during an angiogram the wire coating peeled at the distal tip.It was confirmed no coating/wire fragments were left inside the patient, and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the guidewire was returned for the analysis.Visual inspection revealed that the guidewire was kinked, and polymer jacket peeled at the distal tip section.The physician has provided a photo of the device.As per the photo provided, the distal tip was found kinked and peeled.
Event or Problem Description
It was reported that coating issue occurred.The v-14 control guidewire long taper 300cm straight tip was used for during treatment of peripheral artery disease, however, during an angiogram the wire coating peeled at the distal tip.It was confirmed no coating/wire fragments were left inside the patient, and the procedure was completed.There were no patient complications reported.
Event or Problem Description
It was reported that coating issue occurred.The v-14 control guidewire long taper 300cm straight tip was used for during treatment of peripheral artery disease, however, during an angiogram the wire coating peeled at the distal tip.It was confirmed no coating/wire fragments were left inside the patient, and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
"**udi related data quality updates only** this report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #." device evaluated by mfr.: the guidewire was returned for the analysis.Visual inspection revealed that the guidewire was kinked, and polymer jacket peeled at the distal tip section.The physician has provided a photo of the device.As per the photo provided, the distal tip was found kinked and peeled.

• Brand Name: V-14 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 MN ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18095049
• Report Number: 2124215-2023-62545
• Device Sequence Number: 5945284
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: (01)08714729799269(17)20250424(10)0031491004
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/24/2024

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: 04/24/2025
• Device Model Number: H74939216930010
• Device Catalogue Number: 40458
• Device Lot Number: 0031491004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 11/17/2023; 01/16/2024; 07/08/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/14/2023; 02/09/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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