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

Model Number	1973-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that restenosis occurred.On (b)(6) 2023, the patient had a non-healing wound to the left foot trans-metatarsal amputation site and angiogram revealed left leg revascularization (previous intervention was unknown).The aorta and bilateral common, external, and internal iliac arteries were patent.The left common femoral, profunda femoris, and popliteal arteries were patent.The left superficial femoral artery (sfa) was patent with scattered areas of severe stenosis, and single-vessel runoff to the left foot through the peroneal artery with areas of severe stenosis.The catheter was advanced to the left superficial femoral, popliteal, and peroneal arteries with selective angiography at each level.A rotablator atherectomy device and 5 mm ranger drug-coated balloon was used for treatment of the sfa.The left peroneal artery was treated with a 2.5 mm plain balloon.Good result from revascularization of the left superficial femoral peroneal arteries with significantly improved flow lumen and more brisk filling down to the foot on completion angiogram.On (b)(6) 2023, the patient returned again with non-healing wound to the left foot trans-metatarsal amputation site and angiogram again revealed left leg revascularization.Intravascular ultrasound revealed left sfa occluded in the proximal thigh just a few centimeters past its origin with reconstitution at hunter's canal.The popliteal was patent though diffusely diseased with areas of scattered stenosis most notably around the knee and the tibioperoneal trunk was patent with moderate stenosis noted.The single-vessel runoff to the left foot through the peroneal artery was small and diffusely diseased though patent.Intravascular ultrasound showed the common femoral artery to be about 5 mm in diameter and patent, where the occluded sfa vessel diameters measured 3.54 mm.The popliteal measured 3-4 mm, tibioperoneal trunk and proximal peroneal arteries measured 2.3 mm.The catheter was advanced and a 2.2 mm phoenix atherectomy device was used to treat the sfa and popliteal arteries down to the level of the knee.The popliteal artery was also treated using a 4 mm plain balloon, and the sfa was further treated with angioplasty using 5 mm plain balloon.Follow-up angiogram performed, and intravascular ultrasound was used to evaluate the previously imaged femoral through proximal peroneal arteries.With satisfactory result, catheter and sheath and wire removed.It was noted that there was good result from revascularization with restoration of single vessel runoff to the left foot.The left lower extremity arterial tree was diffusely small but good caliber flow lumen throughout the revascularized superficial and popliteal arteries with brisk filling down to the foot.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• 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: 18360423
• Report Number: 2124215-2023-72283
• Device Sequence Number: 12698474
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: 08714729976042
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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: 01/31/2025
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 01013H23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown