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

Model Number	H74939419501510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Embolism/Embolus (4438); Reduced Blood Flow (4598)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that slow flow was observed, requiring medical intervention.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery to anterior tibial artery.After pre-dilation was performed, contrast observed no slow flow.A 6.0 x 150mm, 150cm ranger drug coated balloon was used; however, the balloon ruptured during first dilation at 6 atmospheres.At almost the same time, the patient moved the operated leg significantly.The angle was approximate, but the hip joint was abducted for about 30 degrees while the operated knee was extended.A 5.0 x 150mm, 150cm and 6.0 x 200mm, 150cm ranger drug coated balloons were used, but a slow flow was observed.A final contrast confirmed the slow flow.A nitroglycerin was administered to improve the flow, and the patient's blood pressure temporarily decreased, but it returned within few minutes.There was no effect on the patient's overall condition after the procedure.Another contrast performed after 3 minutes showed no improvement, but it was eventually resolved.The possibility of distal embolization was considered the cause of the slow flow.It was further reported that no balloon fragments were left behind in the patient and was removed intact.
Event or Problem Description
It was reported that slow flow was observed, requiring medical intervention.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery to anterior tibial artery.After pre-dilation was performed, contrast observed no slow flow.A 6.0 x 150mm, 150cm ranger drug coated balloon was used; however, the balloon ruptured during first dilation at 6 atmospheres.At almost the same time, the patient moved the operated leg significantly.The angle was approximate, but the hip joint was abducted for about 30 degrees while the operated knee was extended.A 5.0 x 150mm, 150cm and 6.0 x 200mm, 150cm ranger drug coated balloons were used, but a slow flow was observed.A final contrast confirmed the slow flow.A nitroglycerin was administered to improve the flow, and the patient's blood pressure temporarily decreased, but it returned within few minutes.There was no effect on the patient's overall condition after the procedure.Another contrast performed after 3 minutes showed no improvement, but it was eventually resolved.The possibility of distal embolization was considered the cause of the slow flow.
Additional Manufacturer Narrative
Correction - h6.Patient code.This report was amended to update international medical device regulators forum (imdrf) codes.Incomplete coding of this event was identified during a retrospective review of complaints associated with capa-8580, which focused on identifying and remediating incomplete coding of events.Device analysis results.The device was not returned for analysis; therefore, a technical analysis could not be performed.Device history review: it was confirmed that this device met manufacturing specification prior to distribution and there are no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was considered known inherent risk of device.
Event or Problem Description
It was reported that slow flow was observed, requiring medical intervention.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery to anterior tibial artery.After pre-dilation was performed, contrast observed no slow flow.A 6.0 x 150mm, 150cm ranger drug coated balloon was used; however, the balloon ruptured during first dilation at 6 atmospheres.At almost the same time, the patient moved the operated leg significantly.The angle was approximate, but the hip joint was abducted for about 30 degrees while the operated knee was extended.A 5.0 x 150mm, 150cm and 6.0 x 200mm, 150cm ranger drug coated balloons were used, but a slow flow was observed.A final contrast confirmed the slow flow.A nitroglycerin was administered to improve the flow, and the patient's blood pressure temporarily decreased, but it returned within few minutes.There was no effect on the patient's overall condition after the procedure.Another contrast performed after 3 minutes showed no improvement, but it was eventually resolved.The possibility of distal embolization was considered the cause of the slow flow.It was further reported that no balloon fragments were left behind in the patient and was removed intact.

• 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 ; 7634941632
• MDR Report Key: 21308807
• Report Number: 2124215-2025-03167
• Device Sequence Number: 18354746
• Product Code: ONU
• UDI-Device Identifier: 08714729976028
• UDI-Public: 08714729976028
• 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,Followup,Followup
• Report Date (Section B): 04/22/2026

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: 04/23/2026
• Device Model Number: H74939419501510
• Device Catalogue Number: H74939419501510
• Device Lot Number: 03765H24
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 02/05/2025; 03/30/2026
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/27/2025; 04/22/2026
• Date Device Manufactured: 04/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female