MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER?; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	H74939419602010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: age at time of event: 71 years old at the time of study enrollment.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported via a clinical study that vessel occlusion occurred, requiring intervention.On (b)(6) 2024, a right lower extremity angiogram revealed occlusion of the superficial femoral artery (sfa) in the region of a proximal stent, and disease of the sfa distally, with good recannulation in the distal sfa and excellent 3 vessel run-off to the foot.An occlusion was noted in right proximal sfa, right mid sfa, right distal sfa, and right popliteal artery, which were treated by balloon angioplasty using these two 6 x 200 mm ranger drug coated balloons.This was followed by placement of a 6 mm x 50 mm non-boston scientific endoprosthesis stent in the right proximal sfa, and was post dilated using a 6 mm x 40 mm ranger drug coated balloon.Post procedure, the final residual stenosis was noted to be 30%.The event was considered to be resolved and on the same day, the subject was discharged from the hospital.On (b)(6) 2024, the subject presented to the hospital with the complaint of right thigh pain for the previous week, indicative of a new occluded stent or injury to the profunda.On the same day, right lower extremity angiogram revealed a widely patent proximal sfa stent and profunda femoral artery, occlusion of the distal sfa and proximal popliteal artery, with reconstitution of the 3 tibial vessels at the level of the popliteal artery.The subject was noted with a pre-operative diagnosis of peripheral vascular disease and short distance life-limiting claudication.On the same day, the occlusions noted in right distal sfa, and right proximal popliteal artery, were treated by lithotripsy using 5 mm x 60 mm shockwave lithotripsy device and balloon angioplasty using 5 mm x 80 mm and 6 mm x 120 mm drug coated balloons.Post procedure, angiography revealed opened right distal sfa and popliteal artery with moderate disease.On the same day, the event was considered to be resolved.
Event or Problem Description
It was reported via a clinical study that vessel occlusion occurred requiring intervention.On (b)(6) 2024, a right lower extremity angiogram revealed occlusion of the superficial femoral artery (sfa) in the region of a proximal stent, and disease of the sfa distally, with good recannulation in the distal sfa and excellent 3 vessel run-off to the foot.An occlusion was noted in right proximal sfa, right mid sfa, right distal sfa, and right popliteal artery, which were treated by balloon angioplasty using these two 6 x 200 mm ranger drug coated balloons.This was followed by placement of a 6 mm x 50 mm non-boston scientific endoprosthesis stent in the right proximal sfa, and was post dilated using a 6 mm x 40 mm ranger drug coated balloon.Post procedure, the final residual stenosis was noted to be 30%.The event was considered to be resolved and on the same day, the subject was discharged from the hospital.On (b)(6) 2024, the subject presented to the hospital with the complaint of right thigh pain for the previous week, indicative of a new occluded stent or injury to the profunda.On the same day, right lower extremity angiogram revealed a widely patent proximal sfa stent and profunda femoral artery, occlusion of the distal sfa and proximal popliteal artery, with reconstitution of the 3 tibial vessels at the level of the popliteal artery.The subject was noted with a pre-operative diagnosis of peripheral vascular disease and short distance life-limiting claudication.On the same day, the occlusions noted in right distal sfa, and right proximal popliteal artery, were treated by lithotripsy using 5 mm x 60 mm shockwave lithotripsy device and balloon angioplasty using 5 mm x 80 mm and 6 mm x 120 mm drug coated balloons.Post procedure, angiography revealed opened right distal sfa and popliteal artery with moderate disease.On the same day, the event was considered to be resolved.
Additional Manufacturer Narrative
A2: age at time of event: 71 years old at the time of study enrollment.
Event or Problem Description
It was reported via a clinical study that vessel occlusion occurred requiring intervention.On (b)(6) 2024, a right lower extremity angiogram revealed occlusion of the superficial femoral artery (sfa) in the region of a proximal stent, and disease of the sfa distally, with good recannulation in the distal sfa and excellent 3 vessel run-off to the foot.An occlusion was noted in right proximal sfa, right mid sfa, right distal sfa, and right popliteal artery, which were treated by balloon angioplasty using these two 6 x 200 mm ranger drug coated balloons.This was followed by placement of a 6 mm x 50 mm non-boston scientific endoprosthesis stent in the right proximal sfa, and was post dilated using a 6 mm x 40 mm ranger drug coated balloon.Post procedure, the final residual stenosis was noted to be 30%.The event was considered to be resolved and on the same day, the subject was discharged from the hospital.On (b)(6) 2024, the subject presented to the hospital with the complaint of right thigh pain for the previous week, indicative of a new occluded stent or injury to the profunda.On the same day, right lower extremity angiogram revealed a widely patent proximal sfa stent and profunda femoral artery, occlusion of the distal sfa and proximal popliteal artery, with reconstitution of the 3 tibial vessels at the level of the popliteal artery.The subject was noted with a pre-operative diagnosis of peripheral vascular disease and short distance life-limiting claudication.On the same day, the occlusions noted in right distal sfa, and right proximal popliteal artery, were treated by lithotripsy using 5 mm x 60 mm shockwave lithotripsy device and balloon angioplasty using 5 mm x 80 mm and 6 mm x 120 mm drug coated balloons.Post procedure, angiography revealed opened right distal sfa and popliteal artery with moderate disease.On the same day, the event was considered to be resolved.It was further reported that on (b)(6) 2024, the subject presented to hospital with complaint of right thigh pain that began 3 days after the procedure dated (b)(6) 2024, which worsened with walking.Subject could only ambulate about 5 feet before crippling right thigh pain that radiates into the groin.On (b)(6) 2024, the subject was treated with lithotripsy and angioplasty with final residual stenosis of 20%.
Additional Manufacturer Narrative
A2: age at time of event: 71 years old at the time of study enrollment.H6 - patient codes: updated.H6 - impact codes: updated.
Additional Manufacturer Narrative
A2: age at time of event: 71 years old at the time of study enrollment.H6 - patient codes: updated.H6 - impact codes: updated.
Event or Problem Description
It was reported via a clinical study that vessel occlusion occurred requiring intervention.On (b)(6) 2024, a right lower extremity angiogram revealed occlusion of the superficial femoral artery (sfa) in the region of a proximal stent, and disease of the sfa distally, with good recannulation in the distal sfa and excellent 3 vessel run-off to the foot.An occlusion was noted in right proximal sfa, right mid sfa, right distal sfa, and right popliteal artery, which were treated by balloon angioplasty using these two 6 x 200 mm ranger drug coated balloons.This was followed by placement of a 6 mm x 50 mm non-boston scientific endoprosthesis stent in the right proximal sfa, and was post dilated using a 6 mm x 40 mm ranger drug coated balloon.Post procedure, the final residual stenosis was noted to be 30%.The event was considered to be resolved and on the same day, the subject was discharged from the hospital.On (b)(6) 2024, the subject presented to the hospital with the complaint of right thigh pain for the previous week, indicative of a new occluded stent or injury to the profunda.On the same day, right lower extremity angiogram revealed a widely patent proximal sfa stent and profunda femoral artery, occlusion of the distal sfa and proximal popliteal artery, with reconstitution of the 3 tibial vessels at the level of the popliteal artery.The subject was noted with a pre-operative diagnosis of peripheral vascular disease and short distance life-limiting claudication.On the same day, the occlusions noted in right distal sfa, and right proximal popliteal artery, were treated by lithotripsy using 5 mm x 60 mm shockwave lithotripsy device and balloon angioplasty using 5 mm x 80 mm and 6 mm x 120 mm drug coated balloons.Post procedure, angiography revealed opened right distal sfa and popliteal artery with moderate disease.On the same day, the event was considered to be resolved.It was further reported that on (b)(6) 2024, the subject presented to hospital with complaint of right thigh pain that began 3 days after the procedure dated (b)(6) 2024 which worsened with walking.Subject could only ambulate about 5 feet before crippling right thigh pain that radiates into the groin.On (b)(6) 2024, the subject was treated with lithotripsy and angioplasty with final residual stenosis of 20%.It was further reported that the occlusion was located at the right femoropopliteal artery.

• Brand Name: RANGER?
• Common Device Name: 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: 21768986
• Report Number: 2124215-2025-20730
• Device Sequence Number: 20939358
• Product Code: ONU
• UDI-Device Identifier: 08714729976202
• UDI-Public: (01)08714729976202(17)251003(10)9167H23
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/16/2025

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: 10/03/2025
• Device Model Number: H74939419602010
• Device Catalogue Number: H74939419602010
• Device Lot Number: 09167H23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/04/2025; 06/18/2025; 08/21/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/30/2025; 07/15/2025; 09/16/2025
• Date Device Manufactured: 10/04/2023
• 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: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Hispanic