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	Vascular Dissection (3160)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a dissection occurred, requiring an additional stent.The subject underwent treatment with the ranger drug-coated balloons on (b)(6) 2023 as a part of the elegance clinical trial.The first target lesion was in the left proximal superficial femoral artery, left mid superficial femoral artery extending up to left distal superficial femoral artery with 6 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 250 mm with 100% stenosis.Prior to target lesion treatment with study device, atherectomy was performed by using a non-boston scientific (bsc) atherectomy device and pre-dilation was performed by using 4.0 mm x 240 mm non-bsc balloon.Treatment of target lesion was performed by dilation using 5 mm x 200 mm, 6 mm x 200 mm, and 6 mm x 150 mm ranger drug-coated balloons study devices.Following post treatment, dilation was performed by using 5 mm x 120 mm non-bsc balloons, placement of 6.0 mm x 150 mm innova bare metal stent and 6.0 mm x 125 mm non-bsc bare metal stent.Following treatment, the final residual stenosis was noted to be 0%.The second target lesion was in the left proximal popliteal artery, left mid popliteal artery extending up to left distal popliteal artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 100 mm with 70% stenosis.Prior to target lesion treatment with study device, atherectomy was performed by using a non-bsc atherectomy device.Treatment of target lesion was performed by dilation using 5 mm x 200 mm ranger drug-coated balloon study device.Following post treatment, dilation was performed by using 4 mm x 200 mm non-bsc balloon.Following treatment, the final residual stenosis was noted to be 20%.On (b)(6) 2023, on the same day of index procedure, during the treatment of the first target lesion, dissection of grade b and was noted in the target lesion.Additionally, residual stenosis was also noted.Of note, site has confirmed that dissection was due to 6 mm x 150 mm ranger drug-coated balloon.In response to the complication, stent was placed.Post treatment, the final residual stenosis was noted to be 0%.On the same day, the complication of dissection was resolved.On (b)(6) 2023, the subject was discharged from the hospital on clopidogrel.
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).A2: patient age at the time of enrollment: 83 years old.

• 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: 17931548
• Report Number: 2124215-2023-56114
• Device Sequence Number: 12366326
• Product Code: ONU
• UDI-Device Identifier: 08714729976189
• UDI-Public: 08714729976189
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2023

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: 04/11/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 03129H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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 Sex: Male
• Patient Race: White