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	10/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance study.It was reported that a dissection occurred.The subject underwent treatment with the two ranger drug-coated balloons on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was in left distal superficial femoral artery (sfa) extending to left proximal popliteal artery with proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 4 mm.The lesion length of 250 mm with 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment, pre-dilatation was performed with a non-bsc pta balloon 3 mm x 200 mm, then treatment was performed using ranger drug coated balloons of 4.0 mm x 200 mm and 5.0 mm x 60 mm.Post-target lesion treatment, balloon dilation was performed with a non-bsc pta balloon of 4 mm x 120 mm and 5 mm x 120 mm.Following the treatment, the final residual stenosis was noted to be 0%.On (b)(6) 2021, during the index procedure, a dissection of grade b in the target lesion was noted due to study devices and a non-bsc bare metal stent was deployed in response.On the same day, subject was discharged from the hospital on clopidogrel and aspirin.

• 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): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15067984
• Report Number: 2134265-2022-07535
• Device Sequence Number: 17636539
• Product Code: ONU
• UDI-Device Identifier: 08714729975885
• UDI-Public: 08714729975885
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 07/20/2022

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: 10/07/2021
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 0027603322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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: 70 YR
• Patient Sex: Female
• Patient Race: White