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	09/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that restenosis occurred.On (b)(6) 2024, vascular access was obtained via right groin using a 4f sheath.Subsequently, the sheath was exchanged to 45cm 6f sheath.The popliteal artery was pre-dilated using a 2x60mm coyote balloon catheter at 14 atmospheres (atm) for 15 seconds twice, and another 14 atm for 30 seconds.A 4x100mm non-boston scientific (bsc) balloon was advanced, and the popliteal artery was again pre-dilated at 8 atm for 30 seconds and then 14 atm for 30 seconds.The superficial femoral artery (sfa) was pre-dilated at 14 atm for 30 seconds.The popliteal was then dilated using the 5.0 x 100mm, 135cm ranger paclitaxel-coated pta balloon catheter at 14 atm for 180 seconds.A 7x60mm non-bsc stent was deployed in the sfa and was post dilated twice using 5x40mm non-bsc balloon at 14 atm for 12 seconds.The procedure was completed.The patient was transferred in stable condition.On (b)(6) 2024, a 6f contralateral sheath was inserted over the non-bsc guidewire into the left femoral artery around the iliac bifurcation to the right femoral.The catheter was aspirated and flushed, and a non-bsc support catheter was inserted over the guidewire.The guidewire was advanced through the popliteal subtotal occlusion into the tibial peroneal trunk.The catheter was inserted over the guidewire to the tibial peroneal trunk.The guidewire was removed, and the catheter was aspirated and flushed.A rotawire was advanced through the catheter into the distal peroneal.The catheter was removed, leaving the guidewire in place.The groin sheath was aspirated and flushed, and a 2mm burr was inserted over the guidewire into the popliteal.Multiple passes were made in the popliteal.The burr was then removed from the body using dynaglide, leaving the guidewire in place.A 6 mm x 60 mm drug-coated balloon was inserted over the guidewire into the lesion.The balloon was inflated to 10 atm for 3 minutes.The balloon was then deflated and removed from the body.The pre-procedure stenosis was 99%.The post-procedure stenosis was 50%.The patient tolerated the procedure without complications and left the cath lab in stable hemodynamic condition with a palpable pulse in 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: 20462233
• Report Number: 2124215-2024-62668
• Device Sequence Number: 18084054
• Product Code: ONU
• UDI-Device Identifier: 08714729975984
• UDI-Public: 08714729975984
• 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): 10/16/2024

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: 03/11/2026
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 02401H24
• 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: 09/17/2024
• Initial Report FDA Received Date: 10/16/2024
• Date Device Manufactured: 03/11/2024
• 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: 72 YR
• Patient Sex: Male