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	Ischemia (1942); Obstruction/Occlusion (2422)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported there was ischemia/occlusion of treated right superficial femoral artery (sfa).On (b)(6) 2022, a ranger drug-coated balloon was used during a treatment procedure for peripheral arterial disease with claudication.Utilizing roadmap imaging, a glidewire and rubicon crossing catheter were advanced through the sfa occlusion into the popliteal artery.The anterior tibia artery origin was then selected.The wire and catheter were advanced down to the distal anterior tibial artery.Intraluminal position was confirmed by catheter injection.Atherectomy of the sfa, popliteal and proximal anterior tibia artery was then performed with a rotablator 2.0 mm atherectomy device.Balloon angioplasty was then performed, first to the anterior tibia artery with a 3 x 100 mm balloon inflated to full profile for 3 minutes.The popliteal and sfa was then treated with a 4 x 150 mm ranger drug-coated balloon inflated to full profile for 3 minutes.The sfa was then treated with a 5 x 200 mm balloon inflated to full profile for 3 minutes.Final imaging showed an excellent result, with no significant residual stenosis end brisk flow to the foot.On (b)(6) 2022, the patient presented with lower extremity ischemia and occlusion of the treated sfa.Atherectomy of the sfa, popliteal and proximal anterior tibial artery was performed with a rotablator 2.0 mm atherectomy device.Imaging following atherectomy showed a patent but small flow channel.Balloon angioplasty was then performed first to the anterior tibial artery with a 3 x 20 mm balloon inflated for 3 minutes.The popliteal and distal superficial femoral arteries were then treated with a 4 x 200 mm balloon inflated for 3 minutes.Repeat images show a significant residual in stenosis at the proximal occlusion cap in the distal sfa.An eluvia drug-eluting stent was deployed in standard fashion in the distal sfa, and post-dilated with a 5 x 150 mm balloon.Final imaging showed an excellent result with no residual stenosis and brisk flow 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; two scimed place; maple grove MN 55311
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15628847
• Report Number: 2124215-2022-41535
• Device Sequence Number: 20627818
• Product Code: ONU
• UDI-Device Identifier: 08714729975861
• UDI-Public: 08714729975861
• 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): 10/18/2022

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: 01/27/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 00833H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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 Age: 59 YR
• Patient Sex: Unknown