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	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon became entrapped on the guidewire.The target lesion was located in the anterior tibial artery.A 3.0mm x 150mm x 150cm sterling sl balloon catheter and a 182cm v-14 control wire were selected for use.The balloon was advanced for dilation.However, it was noted that the balloon got stuck when advancing into the guidewire.So physician decided to remove the balloon and the guidewire, but the guidewire gets trapped inside the balloon and the balloon was completely damaged when attempting to separate.The procedure was completed with another of same device.There were no patient complications reported.
Event or Problem Description
It was reported that the balloon became entrapped on the guidewire.The target lesion was located in the anterior tibial artery.A 3.0mm x 150mm x 150cm sterling sl balloon catheter and a 182cm v-14 control wire were selected for use.The balloon was advanced for dilation.However, it was noted that the balloon got stuck when advancing into the guidewire.So physician decided to remove the balloon and the guidewire, but the guidewire gets trapped inside the balloon and the balloon was completely damaged when attempting to separate.The procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: analysis of returned product revealed that the distal tip kinked.The reported issues could be confirmed.Additionally, the outer diameter was measured and the results were within specification.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13996254
• Report Number: 2134265-2022-03890
• Device Sequence Number: 5103745
• Product Code: DQX
• UDI-Device Identifier: 08714729799207
• UDI-Public: 08714729799207
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 06/02/2022

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: 09/24/2023
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0028084226
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 85 KG