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

Model Number	40458
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire had coating issues.A 300cm v-14 control wire guidewire was selected for peripheral angioplasty.During the procedure, the physician noted that the guidewires felt not rigid enough and hydrophilic coating was lost during navigation.By the time the guidewire was used for platforming, the guidewire got stuck with a non-bsc support catheter.The guidewire and non-bsc support catheter were removed together, and no coating or wire fragments were left inside the patient's body.The procedure was completed with a non-bsc guidewire.No patient complications were reported.
Event or Problem Description
It was reported that the guidewire had coating issues.A 300cm v-14 control wire guidewire was selected for peripheral angioplasty.During the procedure, the physician noted that the guidewires felt not rigid enough and hydrophilic coating was lost during navigation.By the time the guidewire was used for platforming, the guidewire got stuck with a non-bsc support catheter.The guidewire and non-bsc support catheter were removed together, and no coating or wire fragments were left inside the patient's body.The procedure was completed with a non-bsc guidewire.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.Visual inspection was performed, and it was observed that the guidewire was returned stuck inside the non-bsc support catheter.Also, it was observed waste accumulated at the tip and the tip distal was bent.No other issues were identified during the product analysis.

• 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: 19074917
• Report Number: 2124215-2024-18492
• Device Sequence Number: 20525362
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: 08714729799269
• 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
• Report Date (Section B): 10/25/2024

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: 09/24/2025
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0032494627
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SUPPORT CATHETER - BD SEEKER; SUPPORT CATHETER - BD SEEKER
• Patient Age: 68 YR
• Patient Sex: Male