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	Restenosis (4576)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that restenosis occurred.On (b)(6) 2021, a 5.0 x 150mm, 90cm ranger drug coated balloon (dcb) was selected for the treatment of a chronic total occlusion in the left popliteal artery.The lesion was 99% stenosed, mildly calcified and located in a moderately tortuous anatomy.On (b)(6) 2021, restenosis was observed in the treated lesion.Second treatment of the target lesion was performed using a non boston scientific dcb.On (b)(6) 2022, third treatment of the target lesion was performed due to restenosis.The restenosis was treated with a 5.0 x 200mm, 150cm ranger dcb and a 7 x 40, 130cm eluvia drug-eluting stent.During a subsequent follow-up in (b)(6) 2022, echocardiogram and computed tomography scans revealed an aneurysm in the treated site.On (b)(6) 2022 treatment of the aneurysm was performed by implanting a viabahn stent graft and an epic stent over the aneurysm.The aneurysm was resolved and the patient was placed under observation.There were no further patient complications reported.According to the physician, it is believed that there might be a causal relationship between the repeated treatments of the lesion in a short period of time and the use of the non boston scientific balloon, which is a high dose dcb.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14250882
• Report Number: 2134265-2022-04864
• Device Sequence Number: 4887550
• Product Code: ONU
• UDI-Device Identifier: 08714729976035
• UDI-Public: 08714729976035
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2022

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: 02/17/2022
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 0027328127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male