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	03/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
Elegance study.It was reported that vessel dissection occurred, requiring additional intervention.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The first target lesion was in the left distal sfa with 5.00 mm proximal reference vessel diameter and 5.00 mm distal reference vessel diameter with lesion length 60 mm with 100% stenosis and was classified as tasc ii b lesion.Prior to target lesion treatment with the study device, pre-dilation was performed using 5 mm x 60 mm sterling pta balloon.Treatment of target lesion was performed with study device, 5 mm x 60 mm ranger drug coated balloon.The final residual stenosis was noted to be 0%.The second target lesion was in the left mid popliteal artery with 4.3 mm proximal reference vessel diameter and 4.3 mm distal reference vessel diameter with lesion length 40 mm with 80 % stenosis and was classified as tasc ii a lesion.Prior to target lesion treatment with study device, pre-dilatation was performed using 4 mm x 40 mm sterling pta balloon.Treatment of target lesion was performed with study device, 4 mm x 40 mm ranger drug coated balloon.The final residual stenosis was noted to be 0%.On (b)(6) 2022, on the same day of index procedure, during the treatment of the second target lesion, non-flow limiting dissection of grade a was noted due to 4mm x 40mm ranger drug coated balloon.Per edc, in response to the event, balloon dilation was performed.Post treatment, the final residual stenosis was noted to be 0%.Per edc, the complication of dissection was resolved.On the same day, the subject was discharged on dual antiplatelet therapy.

• 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: 15904570
• Report Number: 2124215-2022-46963
• Device Sequence Number: 5775535
• Product Code: ONU
• UDI-Device Identifier: 08714729975762
• UDI-Public: 08714729975762
• Combination Product (Y/N): Y
• Initial Reporter State: DC
• 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): 12/02/2022

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: 07/08/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 04263H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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: Female
• Patient Race: White