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

Model Number	H74939419401010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pain in the left lower extremity.On (b)(6)2022, the patient underwent treatment of a target lesion in the mid-to-distal superficial femoral artery using a 4.0 x 100 mm, 135 cm ranger drug-coated balloon.The balloon was inflated to 8 atmospheres for 180 seconds.On (b)(6)2024, the patient experienced pain in the left lower extremity involving calf and radiating to foot.Additional intervention was performed using drug-coated balloon (dcb) angioplasty and balloon angioplasty.The event subsequently resolved on (b)(6)2025.
Additional Manufacturer Narrative
A4: weight: 59.2.D4: lot number- 00518422 was provided; however, the lot number provided did not match a ranger balloon.Good faith effort was made to confirm the lot number, but confirmation has not been obtained at the time this report was sent.Because the product lot number is not confirmed, we are unable to provide the complete unique identifier (udi) #.

• 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: 50255881
• Report Number: 2124215-2026-43700
• Device Sequence Number: 15983832
• Product Code: ONU
• UDI-Device Identifier: 08714729975823
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2024
• Device Model Number: H74939419401010
• Device Catalogue Number: H74939419401010
• Device Lot Number: 00518H22
• 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: 07/16/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 01/11/2022
• 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 Age: 74 YR
• Patient Sex: Female