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	Thrombosis/Thrombus (4440)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that acute thrombosis occurred, requiring intervention.A 5.0 x 200mm, 150cm ranger paclitaxel-coated pta balloon catheter was selected for use in an abdominal aortogram, bilateral lower extremity arteriogram, and selective left lower extremity arteriogram from the common femoral artery.A boston scientific pathways atherectomy device was selected and advanced through the vessel to treat the occlusion.Once atherectomy was completed, angiogram showed flow but there was significant debris in the filter restricting flow, but no high-grade obstruction was seen.The ranger balloon catheter was passed down to just above the knee joint and the entire length of the popliteal proximally and the entire length of the superficial femoral artery was balloon dilated serially with each inflation being taken to nominal or supra nominal pressure with multiple waists noted and complete expansion obtained.Each inflation was held for 3 minutes, deflated, and then removed.Following the serial dilation, repeat angiogram showed a patent vessel through but slow flow due to debris within the filter.A burn catheter was then advanced for use, and repeat angiogram showed widely patent superficial femoral and popliteal arteries with no evidence of distal embolization and no indication for additional stenting.One week later, total occlusion of the superficial femoral artery was observed at the origin and throughout its entire length.The popliteal artery was also observed to be totally occluded throughout its entire length.The lesion was accessed with a burn catheter, which easily advanced, indicated acute thrombosis and arteriogram revealed thrombosis in the below-knee popliteal artery.Additional arteriogram showed collateralization to the distal anterior tibial and into the posterior tibial artery.Thrombolysis was used to treat the thromboses, and the patient was transported to intensive care by ambulance for overnight thrombolysis.The patient tolerated the procedure well.

• 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: 18307184
• Report Number: 2124215-2023-68835
• Device Sequence Number: 6783713
• 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): 12/11/2023

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: 04/27/2025
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 03871H23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female