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

Model Number	H74939216730020
Medical Device Problem Codes	Detachment of Device or Device Component (2907); 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	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire coating had peeled, and partial detachment had occurred.The target lesion was located in a moderately tortuous and severely calcified segment of the popliteal artery.A 300 cm v-14 control wire angled tip was selected for use.During the procedure, the guidewire encountered resistance and demonstrated insufficient pushability, prompting the physician to withdraw the device.Upon inspection, the guidewire was found to be bent at the tip with areas of coating loss.The device was removed partially in one piece, with a detached segment found within the introducer sheath upon extraction.Imaging confirmed that no coating fragments or wire materials were left inside the patient.The procedure was successfully completed with a new guidewire, and no patient complications were reported.
Event or Problem Description
It was reported that the guidewires coating had peeled, and partial detachment had occurred.The target lesion was located in a moderately tortuous and severely calcified segment of the popliteal artery.A 300 cm v-14 control wire with an angled tip was selected for use.During the procedure, the guidewire encountered resistance and demonstrated insufficient pushability, prompting the physician to withdraw the device.Upon inspection, the guidewire was found to be bent at the tip with areas of coating loss.The device was removed partially in one piece, with a detached segment found within the introducer sheath upon extraction.Imaging confirmed that no coating fragments or wire materials were left inside the patient.The procedure was successfully completed with a new guidewire, and no patient complications were reported.
Additional Manufacturer Narrative
Media inspection: the device was no returned; nevertheless, there are pictures attached in the parent record, and it is possible to observe that the device was peeled and stretched.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.From the provided media by the healthcare facility, it is possible to observe that the polymer jacket of the device was peeled, stretched and detached, moreover the distal tip was bent.The guidewire was returned, and it was observed that polymer jacket was detached/peeled and stretched at polymer jacket and bent at distal tip.
Event or Problem Description
It was reported that the guidewires coating had peeled, and partial detachment had occurred.The target lesion was located in a moderately tortuous and severely calcified segment of the popliteal artery.A 300 cm v-14 control wire with an angled tip was selected for use.During the procedure, the guidewire encountered resistance and demonstrated insufficient pushability, prompting the physician to withdraw the device.Upon inspection, the guidewire was found to be bent at the tip with areas of coating loss.The device was removed partially in one piece, with a detached segment found within the introducer sheath upon extraction.Imaging confirmed that no coating fragments or wire materials were left inside the patient.The procedure was successfully completed with a new guidewire, and no patient complications were reported.

• 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 ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20668812
• Report Number: 2124215-2024-68903
• Device Sequence Number: 7285692
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: 08714729799238
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2025

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: 09/06/2025
• Device Model Number: H74939216730020
• Device Catalogue Number: H74939216730020
• Device Lot Number: 0032373311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 11/20/2024; 12/27/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/05/2024; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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 Age: 56 YR
• Patient Sex: Male