MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER?; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	H74939419501510
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.
Event or Problem Description
It was reported that a balloon leak occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified right superficial femoral artery.A 5.0 x 150mm, 150cm ranger? drug-coated balloon was selected for use in an endovascular therapy procedure.During the first inflation at 4 atmospheres, the balloon did not inflate.The device was removed without issue, and the procedure was completed with another of the same device.An attempt was made to inflate the device outside the body and a sound like air escaping from the balloon was heard, but it was not visually apparent.Upon inspection, there appeared to be a fissure near the proximal part the balloon.It is possible that the balloon was damaged at some point.There was no patient injury as a result of this event.

• 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): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22946830
• Report Number: 2124215-2025-58226
• Device Sequence Number: 13027135
• Product Code: ONU
• UDI-Device Identifier: 08714729976028
• UDI-Public: (01)08714729976028(17)260711(10)7042H24
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P190019
• 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
• Report Date (Section B): 09/02/2025

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 Expiration Date: 07/11/2026
• Device Model Number: H74939419501510
• Device Catalogue Number: H74939419501510
• Device Lot Number: 07042H24
• 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: 08/04/2025
• Initial Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 07/11/2024
• 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: COYOTE MR; GUIDEWIRE: JUPITER FC
• Patient Sex: Male