MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40495
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: aware date of (b)(6) 2023 used as event date as date is unknown.
Event or Problem Description
It was reported that device detachment occurred.A v-18, 200cm, 8cm poly tip control wire was selected for use.However, during procedure, the wire broke off in the catheter.No patient complications were reported.
Event or Problem Description
It was reported that device detachment occurred.A v-18, 200cm, 8cm poly tip control wire was selected for use.However, during procedure, the wire broke off in the catheter.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event: aware date of 28aug2023 used as event date as date is unknown.Device evaluated by mfr.: the device was returned for the analysis, and it was observed that the guidewire was bent at the distal section.It was observed that the polymer jacket does not present any damage, however, an unknown device was attached to the distal tip section.No more damages or issues were observed on the device.

• 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: 17756624
• Report Number: 2124215-2023-47801
• Device Sequence Number: 12428330
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: 08714729070191
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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: 06/21/2025
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0031877127
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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