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

Model Number 1973-03

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2 - age at time of event: the subject was 70 years old at the time of study enrollment.

Event Description

S2444 elegance.It was reported that the balloon was unable to be fully deflated.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion #001 was in the left common femoral artery with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 6.5 mm with lesion length of 60 mm and 70% stenosis and was classified as tasc ii a lesion.Prior to target lesion treatment, lithotripsy was performed using a non-boston scientific device and treatment of target lesion was performed by study device of 7.0 mm x 80 mm ranger drug coated balloon.Post treatment the final residual stenosis was noted to be 10%.The target lesion #002 was in the right common femoral artery, right ostial superficial femoral artery (sfa) extending into right proximal sfa with proximal reference vessel diameter of 6.5 mm and distal reference vessel diameter of 6.0 mm with lesion length of 80 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment, a non-boston scientific embolization protection device was placed, followed by atherectomy and lithotripsy using two non-boston scientific devices.Treatment of target lesion was performed by study device, 6 mm x 60 mm ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 10%.During the index procedure, the 7 mm x 40 mm ranger drug coated balloon was unable to cross the right mid cfa and hence, device was removed and was not used.On the same day, subsequently, attempts to deliver 6 mm x 60 mm ranger drug coated balloon were unsuccessful.Hence a 0.018-inch non-boston scientific guidewire was advanced into the right sfa, over which delivery of the 6 mm x 60 mm ranger drug coated balloon was successful and was used to treat the right ostial sfa and cfa.Post treatment, the 6 mm x 60 mm ranger drug coated balloon was not fully deflated during the withdrawal and was stuck inside the radial sheath.Hence, the balloon and sheath were removed as one unit.On (b)(6) 2022, subject was discharged with aspirin.

Event Description

S2444 elegance.It was reported that the balloon was unable to be fully deflated.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion #001 was in the left common femoral artery with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 6.5 mm with lesion length of 60 mm and 70% stenosis and was classified as tasc ii a lesion.Prior to target lesion treatment, lithotripsy was performed using a non-boston scientific device and treatment of target lesion was performed by study device of 7.0 mm x 80 mm ranger drug coated balloon.Post treatment the final residual stenosis was noted to be 10%.The target lesion #002 was in the right common femoral artery, right ostial superficial femoral artery (sfa) extending into right proximal sfa with proximal reference vessel diameter of 6.5 mm and distal reference vessel diameter of 6.0 mm with lesion length of 80 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment, a non-boston scientific embolization protection device was placed, followed by atherectomy and lithotripsy using two non-boston scientific devices.Treatment of target lesion was performed by study device, 6 mm x 60 mm ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 10%.During the index procedure, the 7 mm x 40 mm ranger drug coated balloon was unable to cross the right mid cfa and hence, device was removed and was not used.On the same day, subsequently, attempts to deliver 6 mm x 60 mm ranger drug coated balloon were unsuccessful.Hence a 0.018-inch non-boston scientific guidewire was advanced into the right sfa, over which delivery of the 6 mm x 60 mm ranger drug coated balloon was successful and was used to treat the right ostial sfa and cfa.Post treatment, the 6 mm x 60 mm ranger drug coated balloon was not fully deflated during the withdrawal and was stuck inside the radial sheath.Hence, the balloon and sheath were removed as one unit.On (b)(6) 2022, subject was discharged with aspirin.It was further reported that the target lesion #002 was in the right common femoral artery, and right ostial sfa.The target lesion did not extend into the right proximal sfa, as was previously reported.Additionally, post index procedure angiography revealed that there was no injury caused by partially deflated balloon and less than 20% residual stenosis was noted in the right common femoral artery, profunda femoris artery, and sfa, with no evidence of contrast extravasation.Furthermore, the medication the patient was discharged with on (b)(6) 2022 was updated from aspirin to dual antiplatelet therapy.

Manufacturer Narrative

Corrected fields: b5.A1 - patient identifier: (b)(6).A2 - age at time of event: the subject was 70 years old at the time of study enrollment.

• 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: 18607588
• MDR Text Key: 334106674
• Report Number: 2124215-2024-04694
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976103
• UDI-Public: 08714729976103
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 04318H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7.0 MM X 80 MM RANGER DRUG COATED BALLOON; 7.0 MM X 80 MM RANGER DRUG COATED BALLOON
• Patient Sex: Female
• Patient Race: White