MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS

Model Number 1177-01

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

Patient Problem Vascular Dissection (3160)

Event Date 05/01/2023

Event Type  Injury  

Event Description

Elegance clinical trial.It was reported that a dissection occurred.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2023 as a part of the elegance clinical trial.The first target lesion was in the right mid popliteal artery with 4.8 mm proximal reference vessel diameter and 4.8 mm distal reference vessel diameter with lesion length of 20 mm and 60% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by dilation using a 5 mm x 40 mm ranger drug-coated balloon study device.Following treatment, post-dilation was performed using 5 mm x 40 mm sterling pta balloon.Post procedure, the final residual stenosis was noted to be 10%.The second target lesion was in the right distal superficial femoral artery (sfa) extending up to right proximal popliteal artery with 5.4 mm proximal reference vessel diameter and 5.4 mm distal reference vessel diameter with lesion length of 50 mm and 90% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by dilation using a 6 mm x 60 mm ranger drug-coated balloon study device.Following treatment, post-dilation was performed using 5 mm x 40 mm sterling pta balloon.Post procedure, the final residual stenosis was noted to be 10%.During treatment of the target lesion, complication of small focal dissection of grade a was noted in the right popliteal artery post the dilation of the 5 mm x 40 mm and 6 mm x 60 mm ranger drug-coated balloons, which was treated with a 5 mm x 40 mm sterling pta balloon.On the same day, the subject was discharged from hospital on dual antiplatelet therapy.

Manufacturer Narrative

A1: patient identifier: (b)(6).E1 - initial reporter phone: (b)(6).

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19082957
• MDR Text Key: 339876145
• Report Number: 2124215-2024-21761
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2024

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 Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Device Lot Number: 09854H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: White