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

Model Number	40458
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: the complaint device was not returned for analysis.The costumer attached a picture of the device and it is possible to observed that de distal tip was detached; consequently, confirming the reported distal tip "detachment of device or device component" complaint event.
Event or Problem Description
It was reported that distal tip detachment and stent thrombosis occurred.The target lesion was located in the leg.A 300cm straight tip v-14 control wire guidewire was advanced for treatment.However, during the procedure, the distal tip of the wire was broken inside the vessel and thrombosis was noted.The detached portion was removed using a snare and the procedure was completed using alternate method or device.No further patient complications reported and the patient was fully recovered.
Event or Problem Description
It was reported that distal tip detachment and stent thrombosis occurred.The target lesion was located in the leg.A 300cm straight tip v-14 control wire guidewire was advanced for treatment.However, during the procedure, the distal tip of the wire was broken inside the vessel and thrombosis was noted.The detached portion was removed using a snare and the procedure was completed using alternate method or device.No further patient complications reported and the patient was fully recovered.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: the complaint device was not returned for analysis.The costumer attached a picture of the device, and it was observed that the distal tip was detached.H3 other text : photo provided.

• Brand Name: V-14 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15627978
• Report Number: 2124215-2022-39427
• Device Sequence Number: 6546575
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: 08714729799269
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/18/2023
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0028224947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown