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	08/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance clinical study.It was reported that a dissection occurred.The subject was enrolled in the elegance clinical study and the index procedure was performed on (b)(6) 2022.The target lesion was in the right proximal superficial femoral artery (sfa), right mid superficial femoral artery extending into right distal superficial femoral artery with 80% stenosis.Prior to target lesion treatment with study device, pre-dilation was performed with 5 mm x 40 mm sterling otw pta balloon.Treatment of target lesion was performed by study device, 5 mm x 150 mm ranger drug coated balloon.Following post dilation with study device, 5.5 mm x 40 mm supra bare metal stent was implanted which was post dilated with 5 mm x 40 mm sterling pta balloon.The final residual stenosis was noted to be 0%.On (b)(6) 2022, the same day of index procedure, subject was noted with severe lifestyle limiting claudication unresponsive to medical therapy underwent interventional procedure.100% occlusion noted in right mid sfa, and 80% stenosis noted in right distal sfa was successfully accessed which were predilated with 5 mm x 40 mm sterling otw pta balloon.Subsequently, 5 mm x 150 mm ranger drug coated balloon (study device) was deployed, following which severe, flow limiting dissection was noted in mid and distal segment of right sfa.In response, the dissection noted was treated with 5.5 mm x 40 mm non-bsc bare metal stent which was post dilated with 5 mm x 40 mm sterling pta balloon.Post intervention, there was excellent angiographic result noted with marked improvement in flow to 2 vessel run-off.On (b)(6) 2022, the event was considered to be resolved, and on the same day the subject was discharged on aspirin and clopidogrel.

• 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: 15423414
• Report Number: 2124215-2022-33509
• Device Sequence Number: 4679364
• Product Code: ONU
• UDI-Device Identifier: 08714729976028
• UDI-Public: 08714729976028
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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: 01/10/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 00411H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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: 79 YR
• Patient Sex: Female
• Patient Race: White