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

Model Number	H74939419500610
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the radiopaque markers on either side of the balloon were missing.The target lesion was located in the superficial femoral artery (sfa).A 5.0 x 60mm, 135cm ranger drug-coated balloon was selected for angiogram.During the procedure, the balloon was placed on the sterile field and flushed.The balloon was then inserted into the patient's right sfa over an 018 wire.However, before the balloon was inflated, the physician noticed that the radiopaque markers on either side of the balloon were missing.The balloon was removed from the patient and a 5x60 sterling balloon was used instead to complete the case without any harm to the patient.No patient complications were reported.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6128757234
• MDR Report Key: 21351108
• Report Number: 2124215-2025-06953
• Device Sequence Number: 21101930
• Product Code: ONU
• UDI-Device Identifier: 08714729975946
• UDI-Public: 08714729975946
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

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: 04/30/2026
• Device Model Number: H74939419500610
• Device Catalogue Number: H74939419500610
• Device Lot Number: 04084H24
• 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: 01/17/2025
• Initial Report FDA Received Date: 02/10/2025
• Date Device Manufactured: 04/30/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Female