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 Codes	Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that claudication and vessel occlusion occurred.On (b)(6) 2024, patient was presented with bilateral lower extremity claudication.The entire length of the left common femoral, superficial femoral and popliteal arteries was treated with a rotablator atherectomy and done without complications.Patient was in a supine position under local infiltrative anesthesia.A 5.0 x 200mm, 150cm ranger paclitaxel-coated pta balloon catheter was selected and passed to cover the distal popliteal artery and the entire length of the popliteal, superficial femoral and common femoral arteries.The balloon was serially inflated to nominal or supra nominal pressure and held for 3 minutes.The balloon was deflated and removed.Repeat angiogram showed dramatic improvement with excellent flow distally with no evidence of any significant dissections and distal embolization.The catheter and sheath were removed, a non-boston scientific close device was deployed at the puncture site with excellent hemostasis.The patient was taken to the recovery area in stable condition.On (b)(6) 2024, patient experienced recurrent symptoms.Ultrasound study showed reocclusion of the popliteal artery.Selective left lower extremity arteriogram from the external iliac/proximal common femoral artery showed diffuse disease through the common femoral artery and proximal superficial femoral artery with moderate disease as well at the origin of the profunda femoris.The superficial femoral artery was then essentially patent continuously but at hunter's canal there was an abrupt occlusion over the entire length of the above-knee popliteal artery with reconstitution at the level of the knee joint.The below-knee popliteal artery was patent.Lower extremity arteriogram from the below-knee popliteal artery showed 3 vessel runoff proximally with the dominant runoff vessel being the posterior tibial into the foot at the distal anterior tibial appeared to be occluded.The peroneal artery was patent down to just above the ankle and in the collaterals.The entire length of the common femoral, superficial femoral, and above-knee popliteal artery to just below the knee joint was treated with a non boston scientific atherectomy device without complications.A 6 x 200 balloon was advanced for dilatation and a 55 x 150 non boston scientific stent was placed beginning at the level of the knee joint and going proximal up to hunter's canal.The stent was deployed in excellent position.Repeat angiogram showed complete resolution of the irregularity through the above-knee popliteal artery with brisk flow into the below-knee popliteal artery and patency of the infrapopliteal vessels as before with no evidence of any distal embolization.The catheter and sheath were removed, a non-boston scientific close device was deployed at the puncture site with excellent hemostasis.The patient was taken to the recovery area in stable condition.

• 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: 19337210
• Report Number: 2124215-2024-27051
• Device Sequence Number: 6614147
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: 06/01/2025
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 05037H23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2023
• 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: 71 YR
• Patient Sex: Female
• Patient Race: White