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

Model Number	40456
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by mfr: the device was not returned.However, the customer provided one photo of the procedure with the v-14 control wire.The photo provided shows the v-14 control wire bent and deformed.
Event or Problem Description
It was reported that device entrapment occurred.The patient was presented with thrombosis of hero graft and underwent a successful declot procedure with retrograde access.Following a 300cm straight tip v-14 short taper guidewire, an opticross 18 vascular imaging catheter was advanced across the lesion to verify the result; however, during the procedure, the motordrive unit prompted an overload error and shut down.The physician attempted to reinitiate the procedure, but the same error occurred.Angiography confirmed that the opticross 18 vascular imaging catheter was entangled with the 300cm straight tip v-14 short taper guidewire distal to the sheath.When an attempt was made to pull the wire, the vascular imaging catheter could not pass into the sheath.Finally, the physician cut both the imaging catheter and the guidewire outside the sheath.The entangled devices were removed out of the patient body by pulling with force through the sheath.There were no patient complications nor injuries were reported.
Event or Problem Description
It was reported that device entrapment occurred.The patient was presented with thrombosis of hero graft and underwent a successful declot procedure with retrograde access.Following a 300cm straight tip v-14 short taper guidewire, an opticross 18 vascular imaging catheter was advanced across the lesion to verify the result; however, during the procedure, the motordrive unit prompted an overload error and shut down.The physician attempted to reinitiate the procedure, but the same error occurred.Angiography confirmed that the opticross 18 vascular imaging catheter was entangled with the 300cm straight tip v-14 short taper guidewire distal to the sheath.When an attempt was made to pull the wire, the vascular imaging catheter could not pass into the sheath.Finally, the physician cut both the imaging catheter and the guidewire outside the sheath.The entangled devices were removed out of the patient body by pulling with force through the sheath.There were no patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned, and analysis completed.The customer provided one photo of the procedure with the v-14 control wire device.The photo provided shows the procedure that the costumer performed with de v-14 control wire device.Nevertheless, it is not possible to see clearly the device.Only it was observed the guidewire bent and deformed.Visual inspection revealed that the device was returned in two parts.It was observed that the guidewire was bent in the middle section and a mechanical cut in distal section of the device can be observed.The dimensions of the detached device are 58cm and 242cm.No more damages or issues were observed.Under the microscope it was observed that the guidewire was bent in the middle section and a mechanical cut in distal section of the device can be observed.No other issues were identified during the product analysis.Device eval by mfr: the device was not returned.However, the customer provided one photo of the procedure with the v-14 control wire.The photo provided shows the v-14 control wire bent and deformed.

• 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: 17436022
• Report Number: 2124215-2023-40470
• Device Sequence Number: 8913842
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: 08714729799221
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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: 05/23/2025
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0031688904
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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