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	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance study.It was reported that a vessel dissection occurred.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery extending into right distal superficial femoral artery with 6.2 mm proximal reference vessel diameter and 6.3 mm distal reference vessel diameter with lesion length 200 mm with 100 % stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment with study device, pre-dilation was performed using 5 mm x 200 mm non-boston scientific (bsc) balloon.Treatment of target lesion was performed by dilation using study devices, 6 mm x 200 mm, 6 mm x 150 mm and 6 mm x 40 mm ranger drug-coated balloons.Following treatment was performed by placement of 7 mm x 150 mm and 7 mm x 100 mm innova bare metal stents followed by dilation with 6 mm x 80 mm non-bsc balloon and the final residual stenosis was noted to be 0%.On (b)(6) 2023, on the same day of index procedure, during the treatment of the target lesion, dissection of grade b was noted in the target lesion, and the site has confirmed that the dissection was possibly due to 5 mm x 200 mm non-bsc balloon or one of the ranger drug-coated balloons and it is not clear which device led to dissection.In response to the complication, balloon dilation was performed, and stent was placed.Post treatment, the final residual stenosis was noted to be 0%.The complication of dissection was resolved.On (b)(6) 2023, the subject was discharged from the hospital.
Additional Manufacturer Narrative
A1: patient identifier- (b)(6).

• 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: 17618621
• Report Number: 2124215-2023-45187
• Device Sequence Number: 6179887
• Product Code: ONU
• UDI-Device Identifier: 08714729976080
• UDI-Public: 08714729976080
• 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): 08/24/2023

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: 07/06/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 05447H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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: 51 YR
• Patient Sex: Male
• Patient Race: Black Or African American