MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Ranger?; Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Model Number	H74939419500810
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Difficult to Remove (1528); Material Rupture (1546); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, catheter separation, and removal difficulty occurred requiring additional intervention.The 100% stenosed target lesion was located in the severely calcified superficial femoral artery.The lesion was successfully crossed and pre-dilated using a sterling balloon (size unknown).An eluvia stent was then deployed in the lesion.Subsequently, a 5.0 x 80mm, 135cm ranger drug coated balloon was used to treat a more distal popliteal lesion.During a subsequent inflation within the newly placed eluvia stent, the ranger balloon ruptured on the second inflation.The entire catheter shaft was also broken.Following the rupture, the physician experienced significant difficulty retracting the damaged device through the stent, lesion, and sheath.Because the balloon had ruptured, vacuum could not be maintained, and complete deflation could not be confirmed.A snare was required to retrieve the damaged balloon catheter from the patient.The device was removed successfully, and no fragments were reported to have remained in the patient.Upon removal, severe physical damage was noted and was described as being in a "curly-q" configuration.The procedure was completed as planned.There were no patient complications as a result of this event.The patient was stable post procedure.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.

• Brand Name: Ranger?
• 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): FREUDENBERG MEDICAL; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50820244
• Report Number: 2124215-2026-49979
• Device Sequence Number: 10127637
• Product Code: ONU
• UDI-Device Identifier: 08714729975960
• UDI-Public: (01)08714729975960(17)270116(10)499H25
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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 Model Number: H74939419500810
• Device Catalogue Number: H74939419500810
• Device Lot Number: 00499H25
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 01/16/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown