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

Model Number	40495
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire entrapment occurred.During a peripheral intervention procedure, the target lesion was located in a moderately calcified, moderately tortuous, approximately 50% stenosed superficial femoral artery (sfa).Despite the calcified lesion at the sfa, the physician successfully crossed the lesion using this v-18, 200 cm poly tip control wire and performed angioplasty with a 5.0 x 220 mm x 90 cm sterling balloon.Then a 5.0 x 200 mm x 90 cm ranger drug coated balloon was used to treat the popliteal to mid sfa, followed by a 5.0 x 100 mm x 80 cm ranger drug coated balloon to treat the mid to proximal sfa.The 5.0 x 100 mm x 80 cm ranger balloon was inflated to a nominal pressure of 6 atmospheres, and during deflation, the balloon did not deflate completely.The physician attempted for approximately 10 to 15 minutes to deflate the balloon using an encore 26 indeflator device, but this was unsuccessful.Additional attempts were made to retract the balloon near the sheath at the common femoral artery and prick the balloon under ultrasound guidance; however, this was also unsuccessful.The balloon remained partially inflated and could not be withdrawn through the 5f sheath.A surgical cut-down was performed to retrieve the ranger balloon completely and in one piece, along with the v-18, 200 cm poly tip control wire which was noted to be stuck within the ranger device and could not be separated.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter first name: (b)(6).

• 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: 23537101
• Report Number: 2124215-2025-78296
• Device Sequence Number: 18648618
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: (01)08714729070191(17)270721(10)37019376
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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 Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0037019376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/12/2025
• Date Device Manufactured: 07/21/2025
• 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: BALLOON CATHETER: 5X200MMX90CM RANGER.; BALLOON CATHETER: 5X220MMX90CM STERLING.; INDEFLATOR: ENCORE 26.; INTRODUCER SHEATH: 5F.
• Patient Sex: Unknown