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 Vascular Dissection (3160)

Event Date 06/30/2022

Event Type  Injury  

Event Description

It was reported that a dissection occurred during the index procedure.The subject underwent treatment with two ranger paclitaxel-coated pta balloon catheters on (b)(6) 2022 as a part of the elegance clinical trial.The first target lesion was in the left mid popliteal artery extending to left distal popliteal artery with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with lesion length 80 mm.The lesion was 100% stenosis and classified as tasc ii d lesion.Prior to the treatment of target lesion, pre-dilation was performed using 4 mm x 150 mm non-boston scientific pta balloon.Treatment of the target lesion was performed by dilation using study device, 5 mm x 120 mm ranger.Post-treatment was performed by the placement of 6 mm x 80 mm non-boston scientific bare metal stent and dilation using 6 mm x 60 mm sterling pta balloon, and the final residual stenosis of the first lesion was noted to be 10 percent.The second target lesion was in the left mid superficial femoral artery with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with lesion length 120 mm.The lesion was 70% stenosed and classified as tasc ii b lesion.Treatment of the target lesion was performed by dilation using study device, 6 mm x 150 mm ranger.Post-treatment, the final residual stenosis of the second lesion was noted to be 30 percent.On 30-jun-2022, on the same day during index procedure, a small dissection was noted post dilation with the 5 mm x 120 mm ranger drug coated balloon used on the first lesion.In response to the event, as drug-eluding stent was placed for resolution.

Manufacturer Narrative

(b)(6).

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• 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: 18277405
• MDR Text Key: 329859523
• Report Number: 2124215-2023-68844
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2023

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: 01/10/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 00408H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male