MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number 1973-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 03/01/2022

Event Type  Injury  

Event Description

It was reported that an aneurysm 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
• Type of Device: 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: 14250883
• MDR Text Key: 290398359
• Report Number: 2134265-2022-04862
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: 08714729976042
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 05328H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male