MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VICTORY; WIRE, GUIDE, CATHETER

Model Number	VICTORY 14 (300 CM, 30G)
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire entrapment occurred.The patient presented with peripheral artery disease.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified anterior tibial artery.After inserting a 30g victory 14 guidewire, an opticross 18 imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, after the catheter was placed across the lesion and the device was turned on, the catheter twisted upon itself immediately, and no images were obtained.The devices were then removed together as they were inseparable.The procedure was completed with a different wire and a different imaging catheter.No patient complications were reported.
Event or Problem Description
It was reported that guidewire entrapment occurred.The patient presented with peripheral artery disease.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified anterior tibial artery.After inserting a 30g victory 14 guidewire, an opticross 18 imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, after the catheter was placed across the lesion and the device was turned on, the catheter twisted upon itself immediately, and no images were obtained.The devices were then removed together as they were inseparable.The procedure was completed with a different wire and a different imaging catheter.No patient complications were reported.
Additional Manufacturer Narrative
The device was returned for analysis.The guidewires dimensions were measured and found within the specification and the guidewires polymer jacket section has been covered by the hydrophilic coating during manufacturing process.The opticross 18 intravascular catheter was not returned for the investigation.
Event or Problem Description
It was reported that guidewire entrapment occurred.The patient presented with peripheral artery disease.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified anterior tibial artery.After inserting a 30g victory 14 guidewire, an opticross 18 imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, after the catheter was placed across the lesion and the device was turned on, the catheter twisted upon itself immediately, and no images were obtained.The devices were then removed together as they were inseparable.The procedure was completed with a different wire and a different imaging catheter.No patient complications were reported.
Additional Manufacturer Narrative
"**udi related data quality updates only**.This report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #." however, upon further review, it was found that the initial report was filed in error.Bsc does not have reporting requirements for this product.The device was returned for analysis.The guidewires dimensions were measured and found within the specification and the guidewires polymer jacket section has been covered by the hydrophilic coating during manufacturing process.The opticross 18 intravascular catheter was not returned for the investigation.

• Brand Name: VICTORY
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): LAKE REGION MEDICAL INTERNATIONAL; parkmore west business park; galway, gw ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17872771
• Report Number: 2124215-2023-54440
• Device Sequence Number: 5761837
• Product Code: DQX
• UDI-Device Identifier: 00816349012402
• UDI-Public: (01)00816349012402(11)20230512(17)20260430(10)0008207656
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/25/2024

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: 04/30/2026
• Device Model Number: VICTORY 14 (300 CM, 30G)
• Device Catalogue Number: H74939471300300
• Device Lot Number: 0008207656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 10/25/2023; 07/08/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/17/2023; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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: Female
• Patient Race: White