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

Model Number	40456
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The patient presented with peripheral arterial disease.Vascular access was obtained via the femoral artery.The target lesion was located in the mildly tortuous and moderately calcified below-the-knee vessel with normal ejection fraction.A 300cm angled tip v-14 control wire guidewire was advanced.However, during the procedure, the tip of the guidewire broke and lodged inside the patient.The physician did not attempt to remove the detached tip as it was lodged in the very distal dorsal pedis, and the procedure was abandoned.No further complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Media inspection: the device was not returned; nevertheless, two pictures were attached.The first picture is possible to observe that the guidewire was bent at several parts; therefore, the second one is a fluoroscopy picture, and it possible to observe that a part of the guidewire was detached.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Two pictures were attached.The first picture is possible to observe that the guidewire was bent at several parts; therefore, the second one is a fluoroscopy picture, and it possible to observe that a part of the guidewire was detached.The device was returned, and it was observed that the distal section of the guidewire was bent/kinked.The distal tip was detached.The pouch was returned, and it was observed that the pouch information matches with the complaint information.Under the microscope was the distal tip was detached.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.A2 - age at time of event: 18 years or older.Media inspection: the device was not returned; nevertheless, two pictures were attached.The first picture is possible to observe that the guidewire was bent at several parts; therefore, the second one is a fluoroscopy picture, and it possible to observe that a part of the guidewire was detached.
Event or Problem Description
It was reported that tip detachment occurred.The patient presented with peripheral arterial disease.Vascular access was obtained via the femoral artery.The target lesion was located in the mildly tortuous and moderately calcified below-the-knee vessel with normal ejection fraction.A 300cm angled tip v-14 control wire guidewire was advanced.However, during the procedure, the tip of the guidewire broke and lodged inside the patient.The physician did not attempt to remove the detached tip as it was lodged in the very distal dorsal pedis, and the procedure was abandoned.No further complications were reported, and the patient status was stable.

• 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: 15898495
• Report Number: 2124215-2022-47411
• Device Sequence Number: 5044236
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: 08714729799238
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: 11/12/2023
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0028378637
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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: Other
• Patient Sex: Unknown