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	03/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
Elegance clinical trial.It was reported that a dissection of grade d occurred.The subject underwent with a ranger drug coated balloon (dcb) and eluvia drug eluting stent on (b)(6) 2022 as part of the elegance clinical trial.The target lesion #001 was located in the right mid and proximal superficial femoral artery (sfa) with a proximal reference vessel diameter of 6mm, distal vessel diameter of 6mm, lesion length of 250mm, 70% stenosis, and was classified as tasc ii b lesion.Treatment of right proximal popliteal artery was performed by dilation with a 6 x 200mm ranger dcb, followed by a 6 x 20 mm peripheral cutting balloon.The treatment of right proximal sfa and mid sfa was performed by dilation with study device, ranger drug coated balloon of 6.0 mm x 80 mm followed by placement of 6 mm x 120 mm eluvia drug eluting stent.Post dilation, the final residual stenosis was noted to be 30%.On (b)(6) 2022, during the treatment of the target lesion #001, dissection of grade d was noted in the target lesion due to the study device ranger dcb 6 x 80mm.In response to the dissection noted, a 6mm x 120mm eluvia stent was implanted and a balloon dilation was performed.Following post treatment, the final stenosis was noted to be 30%.The event was resolved.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14644741
• Report Number: 2134265-2022-06534
• Device Sequence Number: 4868048
• Product Code: ONU
• UDI-Device Identifier: 08714729976127
• UDI-Public: 08714729976127
• Combination Product (Y/N): Y
• Initial Reporter State: RI
• 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): 06/09/2022

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: 08/03/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 04907H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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 Ethnicity: Hispanic