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

Model Number	40458
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty to remove the guidewire and tip stripped off.Two v-14 control wires were used with development device for a pre-clinical animal study.When the device was withdrawn, significant resistance was felt.The added force and the angle of the wire caused the guidewire lumen to scrape the polymer tip off.Another of the same device was used but experienced the same problem.There were no complications reported.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.D5: operator of device updated from health professional to other and operator of device, other updated to boston scientific engineer.E3: occupation updated from other health care professional to non health care professional.G2: report source: remove health professional.
Event or Problem Description
It was reported that difficulty to remove the guidewire and tip stripped off.Two v-14 control wires were used with development device for a pre-clinical animal study.When the device was withdrawn, significant resistance was felt.The added force and the angle of the wire caused the guidewire lumen to scrape the polymer tip off.Another of the same device was used but experienced the same problem.There were no complications reported.It was further reported that this was an animal study procedure being performed as part of the product development process (pdp) evaluating guidewire tracking and exchange capabilities with a development device.

• 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 DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20129083
• Report Number: 2124215-2024-54716
• Device Sequence Number: 7399206
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: 08714729799269
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: Other
• Device Expiration Date: 03/02/2026
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0033546257
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/03/2024
• Date Device Manufactured: 03/02/2024
• 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