MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Lot Number	04693H25
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stuck on guidewire occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.A 4.0 x 200 mm 200cm ranger paclitaxel-coated pta balloon catheter was selected for use during this endovascular therapy procedure.During the procedure, the ranger device became stuck with a non-boston scientific guidewire.It was noted that the guidewire was inserted from the tip of the balloon and the guidewire appeared from the exit port.When it was advanced further and tried to be inserted into the sheath, it became stiff, and the guidewire could no longer be advanced.The guidewire was removed from the balloon, and the surface of the guidewire was wiped and was reinserted.However, it would no longer come out from the exit port; therefore, a different device of the same size was used, and the procedure was completed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device analysis: during the product analysis a boston scientific 0.018 guidewire was advanced through this device with no resistance experienced.The guidewire used by the customer was not returned for analysis.The device was returned with the loading tool still on the device.The balloon was not subjected to positive pressure.A visual and tactile examination of the shaft found no issues.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at the time.Risk review: a risk review performed for the ranger (dcb) confirmed that the event of catheter froze on wire is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was no problem detected.The device was successfully loaded onto a compatible guidewire during analysis.The reported clinical observation was not confirmed.
Event or Problem Description
It was reported that stuck on guidewire occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.A 4.0 x 200 mm 200cm ranger paclitaxel-coated pta balloon catheter was selected for use during this endovascular therapy procedure.During the procedure, the ranger device became stuck with a non-boston scientific guidewire.It was noted that the guidewire was inserted from the tip of the balloon and the guidewire appeared from the exit port.When it was advanced further and tried to be inserted into the sheath, it became stiff, and the guidewire could no longer be advanced.The guidewire was removed from the balloon, and the surface of the guidewire was wiped and was reinserted.However, it would no longer come out from the exit port; therefore, a different device of the same size was used, and the procedure was completed.There were no patient complications as a result of this event.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24121714
• Report Number: 2124215-2026-03661
• Device Sequence Number: 21255200
• Product Code: ONU
• UDI-Device Identifier: 00191506046675
• UDI-Public: (01)00191506046675(17)270509(10)4693H25
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 03/04/2026

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 Lot Number: 04693H25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• 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
• Patient Sex: Unknown