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

Model Number	H74939419602010
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a packaging issue occurred.The stenosed target lesion was located in the peripheral artery.A 6.0 x 200mm, 150cm ranger balloon catheter was selected for use.Prior to the procedure, it was noted that the outer box and inner package did not correspond with each other.The outer shipping container was intact with no evidence of prior opening or damage.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device was returned for analysis.Upon visual examination, no damage or issues were identified with the device itself.Additionally, the packaging showed no signs of damage.However, during inspection, it was noted that the information printed on the inner pouch labeling did not match the information printed on the outer box carton labeling.
Event or Problem Description
It was reported that a packaging issue occurred.The stenosed target lesion was located in the peripheral artery.A 6.0 x 200mm, 150cm ranger balloon catheter was selected for use.Prior to the procedure, it was noted that the outer box and inner package did not correspond with each other.The outer shipping container was intact with no evidence of prior opening or damage.There were no patient complications 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: 22066119
• Report Number: 2124215-2025-32413
• Device Sequence Number: 7811724
• Product Code: ONU
• UDI-Device Identifier: 08714729976202
• UDI-Public: (01)08714729976202(17)260821(10)8567H24
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 08/21/2026
• Device Model Number: H74939419602010
• Device Catalogue Number: H74939419602010
• Device Lot Number: 08567H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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 Sex: Unknown