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

Lot Number	02372H25
Medical Device Problem Codes	Deflation Problem (1149); Stretched (1601); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) medical & science center.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that balloon slow deflation occurred.The 100% stenosed target lesion was located in the superficial femoral artery.A 7.0 x 100 mm 200cm ranger (dcb) was advanced for dilation.During the procedure, resistance was encountered while withdrawing the catheter from the hoop.The guidewire was successfully advanced to the lesion site, and the balloon was inflated.However, deflation took longer than usual.Upon removal, the catheter appeared elongated, confirmed visually and the procedure was completed using this device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon slow deflation occurred.The 100% stenosed target lesion was located in the superficial femoral artery.A 7.0 x 100 mm 200cm ranger (dcb) was advanced for dilation.During the procedure, resistance was encountered while withdrawing the catheter from the hoop.The guidewire was successfully advanced to the lesion site, and the balloon was inflated.However, deflation took longer than usual.Upon removal, the catheter appeared elongated, confirmed visually and the procedure was completed using this device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The ranger device was received advanced through its protective hoop.The device was removed from the hoop without issue; therefore, the reported removal issue could not be confirmed.A visual examination identified that the balloon was not folded which indicated that it was subjected to positive pressure.The device was inflated to rated burst pressure and deflated in a time which was within specification, therefore the balloon deflation issue could not be confirmed.The shaft of the device was found to be severely stretched.An examination of the tip and markerbands found no issues.No other issues were identified during the product analysis.

• 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: 23369751
• Report Number: 2124215-2025-75848
• Device Sequence Number: 10122112
• Product Code: ONU
• UDI-Device Identifier: 00191506046859
• UDI-Public: (01)00191506046859(17)270306(10)02372H25
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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 Lot Number: 02372H25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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: INTRODUCER SHEATH - OPTIMO 6F.; INTRODUCER SHEATH - OPTIMO 6F.
• Patient Sex: Unknown