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

Model Number	40456
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire detachment occurred.The severely occluded target lesion was located in the severely calcified lower limb.A 300cm v-14 control wire guidewire was advanced into the vascular cavity through the guide catheter.However, the device was unable to cross the lesion.Upon retrieval of the guidewire, the tip was fractured and fell off into the middle segment of anterior tibial artery.Repeated angiography showed that the broken tip was not found in the vascular lumen, but in the gap between the vascular lumen and muscle.The vascular itself had plaque sclerosis occlusion, so the passing rate is low.When passing through the narrow part, there will inevitably be pressure and resistance when withdrawing.Angiography indicated that the broken tip was not in the vascular cavity, and there were no severe lower limb ischemia symptoms, so it was not removed.The procedure was cancelled.Amputation might be required as the patient had severe occlusion as per medical opinion.There were no further patient complications reported.Post procedure, the patient recovered fairly well, and no severe lower limb ischemia symptoms appeared.
Additional Manufacturer Narrative
Device evaluation by mfr: the complaint device was not returned by the customer, nevertheless the customer did provide pictures related to the complaint where is possible to observe a x-ray photos with the wire distal tip section detached.Consequently, confirming the reported complaint related to distal tip detachment of device or device component and the patient condition unretrieved device fragments.
Event or Problem Description
It was reported that guidewire detachment occurred.The severely occluded target lesion was located in the severely calcified lower limb.A 300cm v-14 control wire guidewire was advanced into the vascular cavity through the guide catheter.However, the device was unable to cross the lesion.Upon retrieval of the guidewire, the tip was fractured and fell off into the middle segment of anterior tibial artery.Repeated angiography showed that the broken tip was not found in the vascular lumen, but in the gap between the vascular lumen and muscle.The vascular itself had plaque sclerosis occlusion, so the passing rate is low.When passing through the narrow part, there will inevitably be pressure and resistance when withdrawing.Angiography indicated that the broken tip was not in the vascular cavity, and there were no severe lower limb ischemia symptoms, so it was not removed.The procedure was cancelled.Amputation might be required as the patient had severe occlusion as per medical opinion.There were no further patient complications reported.Post procedure, the patient recovered fairly well, and no severe lower limb ischemia symptoms appeared.

• 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
• MDR Report Key: 11798825
• Report Number: 2134265-2021-05630
• Device Sequence Number: 3854787
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: 08714729799238
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 02/09/2022
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0025185453
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 55