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	06/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip detached and remained inside the patient.A v-14 control wire was selected for use in a pulmonary balloon angioplasty procedure to treat stenosis in a lung vessel.During the procedure, while dilating the lung vessel as usual, 1mm of the tip coating detached.The device fragment was not removed and remained in the lung without issues.The procedure was successfully completed with this device.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this v-14 control wire was inspected.The returned device matched with the upn provided by the customer.Visual inspection revealed that the distal tip was bent, with a section of the core wire exposed due to the detached polymer jacket.Microscopic inspection confirmed that the polymer jacket detached and the tip was visible.The device was measured in three sections (distal - medium - proximal) and confirmed that it was within specification.
Event or Problem Description
It was reported that the tip detached and remained inside the patient.A v-14 control wire was selected for use in a pulmonary balloon angioplasty procedure to treat stenosis in a lung vessel.During the procedure, while dilating the lung vessel as usual, 1mm of the tip coating detached.The device fragment was not removed and remained in the lung without issues.The procedure was successfully completed with this device.No patient complications were reported.

• 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: 12054233
• Report Number: 2134265-2021-07905
• Device Sequence Number: 14558885
• Product Code: DQX
• UDI-Device Identifier: 08714729799207
• UDI-Public: 08714729799207
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: 03/03/2023
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0026907754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/29/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other