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

Model Number	H74939419600810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that restenosis occurred less than one year post index procedure.On (b)(6) 2023, the initial procedure occurred to treat the patient with peripheral vascular disease and significant claudication.During the procedure, right femoral angiography, selective left lower extremity angiography, atherectomy, and drug-coated balloon angioplasty of the left superficial femoral artery (sfa) were performed.Pre-procedure stenosis of the left sfa was 99%, with a heavily calcified mid segment as well as 90% stenosis in a previously placed stent in the mid distal sfa.Atherectomy was performed using a non-boston scientific device, followed by angioplasty with a 6 mm x 80 mm ranger drug-coated balloon at 17 atm for 3 minutes, reducing stenosis from 99% to 25%.The procedure was completed without complications, and the access site was closed with an angio-seal.On (b)(6) 2024, due to restenosis of the treated segment, the patient underwent a second intervention consisting of right femoral angiography, selective left lower extremity angiography, atherectomy, and repeat balloon angioplasty.After accessing the right common femoral artery retrogradely with a 7-fr contralateral sheath, angiography confirmed 99% restenosis in the sfa.Atherectomy was again performed using a non-boston scientific device, followed by angioplasty with a 6 mm x 80 mm ranger drug-coated balloon at 12 atm for 3 minutes and additional dilation with a 7 mm x 60 mm balloon at 14 atm.Post procedure, residual stenosis was reduced to 10%.The procedure was well tolerated, with no complications, and the access site was closed with an angio-seal.The patient left the cath lab in stable hemodynamic condition with palpable foot pulses.

• 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: 20845571
• Report Number: 2124215-2024-74300
• Device Sequence Number: 3730281
• Product Code: ONU
• UDI-Device Identifier: 08714729976127
• UDI-Public: 08714729976127
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 12/04/2024

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: 03/16/2025
• Device Model Number: H74939419600810
• Device Catalogue Number: H74939419600810
• Device Lot Number: 02601H23
• 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: 11/05/2024
• Initial Report FDA Received Date: 12/04/2024
• Date Device Manufactured: 03/17/2023
• 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: 64 YR
• Patient Sex: Male