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 Problems Ischemia (1942); Numbness (2415); Obstruction/Occlusion (2422)

Event Date 01/11/2022

Event Type  Injury  

Event Description

(b)(6) study.It was reported the patient experienced right foot ischemia.The subject was enrolled in the (b)(6) study on (b)(6) 2022 and the patient underwent treatment with ranger paclitaxel-coated pta balloon catheter on the same day.Target lesion was 60mm long with 100% stenosis and located in the right proximal, mid and distal superficial femoral artery (sfa).The proximal an distal reference vessel diameter were both 5mm.Prior to target lesion treatment with ranger 5.0 x 60mm x 135cm, lithotripsy was performed with shockwave and pre-dilatation performed with the study device.The final residual stenosis was noted to be unknown.On (b)(6) 2022, the subject presented with symptoms of cold and numbness in the right foot related to ischemia.In response to the event, right leg ankle brachial index was performed to compare blood pressure in upper and lower limbs and a drug-coated balloon angioplasty was performed in the right sfa.On (b)(6) 2022, the subject had 100% stenosis in the right sfa and was treated with a bare metal stent placement.No further information was available at this time.

Event Description

Elegance clinical study: it was reported the patient experienced right foot ischemia.The subject was enrolled in the elegance study on (b)(6) 2022 and the patient underwent treatment with ranger paclitaxel-coated pta balloon catheter on the same day.Target lesion was 60mm long with 100% stenosis and located in the right proximal, mid and distal superficial femoral artery (sfa).The proximal an distal reference vessel diameter were both 5mm.Prior to target lesion treatment with ranger 5.0 x 60mm x 135cm, lithotripsy was performed with shockwave and pre-dilatation was performed with the study device.The final residual stenosis was noted to be unknown.On (b)(6) 2022, the subject presented with symptoms of cold and numbness in the right foot related to ischemia.In response to the event, right leg ankle brachial index was performed to compare blood pressure in upper and lower limbs and a drug-coated balloon angioplasty was performed in the right sfa.On (b)(6) 2022, the subject presented to the emergency room with the existing symptoms of cold and numb right toes.Subsequently, right leg ankle brachial index (abi) was performed which revealed right abi 0.30 and left abi 1.058.There was no doppler signal noted in the right dorsal pedal artery and posterior tibial artery.The right great toe pressure was ischemic whereas the left great toe pressure was reduced, but not ischemic.On (b)(6) 2022, arterial duplex was performed which revealed short segment total occlusion in the mid to distal superficial artery and total occlusion noted in the mid to distal posterior tibial arteries and anterior tibial arteries respectively.The resting abi was noted to be 0.37.On (b)(6) 2022, 100% stenosis noted in right sfa was treated by performing balloon angioplasty with a 5 mm x 60 mm charger balloon.Subsequent angiography performed revealed marked improvement of flow through the area of occlusion with minimal stenosis in the right sfa.A self-expanding stent of 5 mm x 60 mm was deployed across the occluded area in the right sfa.Completion angiography showed minimal residual stenosis.

Manufacturer Narrative

Updates made to: b5: describe event or problem.H6: patient codes.

• 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: 13700578
• MDR Text Key: 286856719
• Report Number: 2134265-2022-02427
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729975946
• UDI-Public: 08714729975946
• 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: 04/05/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 05741H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 03/11/2022
• Supplement Dates FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Race: White