MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40495
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the wire coating was detached.The 95% stenosed target lesion was located in the moderately tortuous and non-calcified pulmonary artery.A 200cm, 8cm poly tip v-18 control wire was advanced into the lesion, but it was unsuccessful.A non-boston scientific microcatheter was used to support the wire.After several manipulations, an opaque object was observed under fluoroscopy.It appeared to be a piece of the covered polymer or a fragment of the severed wire.The detached wire coating was attempted to be retrieved using a snare, but it was unsuccessful.A 300cm, 8cm poly tip v-18 control wire was advanced but failed to cross.The procedure was completed with a different device.No complications were reported, and the patient's condition at the end of the procedure was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual inspection observed that the distal tip was bent.Based on the evidence, the reported allegation of guidewire difficulty advancing was confirmed, due to the bent found during product analysis and to the patient's conditions reported in the event.The reported coating issue was not confirmed, since this issue was not found during product inspection.
Event or Problem Description
It was reported that the wire coating was detached.The 95% stenosed target lesion was located in the moderately tortuous and non-calcified pulmonary artery.A 200cm, 8cm poly tip v-18 control wire was advanced into the lesion, but it was unsuccessful.A non-boston scientific microcatheter was used to support the wire.After several manipulations, an opaque object was observed under fluoroscopy.It appeared to be a piece of the covered polymer or a fragment of the severed wire.The detached wire coating was attempted to be retrieved using a snare, but it was unsuccessful.A 300cm, 8cm poly tip v-18 control wire was advanced but failed to cross.The procedure was completed with a different device.No complications were reported, and the patient's condition at the end of the procedure was stable.

• Brand Name: V-18 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 CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20052101
• Report Number: 2124215-2024-51977
• Device Sequence Number: 20807449
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: 08714729070191
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: 03/07/2026
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0033580643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: STYKER EXCELSIOR 1810.; MICROCATHETER: STYKER EXCELSIOR 1810.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown