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

Model Number	1973-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance study trial.It was reported that a thrombosis occurred after a stent was placed.The subject underwent treatment with two ranger paclitaxel-coated pta 6.0 mm x 200 mm and 6.0 mm x 100 mm balloon catheters on 17-mar-2022 as a part of the elegance clinical trial.Target lesion was located in the right proximal, mid and distal superficial femoral artery with 100% stenosis and was 280mm long (diameter 6.0mm proximal and 5.0mm distal) and was classified as tasc ii d lesion.Prior to target lesion treatment, spiderfx embolization protection device was used and atherectomy was performed using jetstream xc followed by pre dilation with 5.0 mm x 220 mm sterling balloon and 5.0 mm x 200 mm vanguard iep pta balloon.During treatment of target lesion with the ranger balloon catheters thrombosis was observed.Atherectomy and aspiration was performed in response to the event, and the complication was resolved.The final residual stenosis was noted to be 0% and no thrombus was seen in the treated vessel at the end of the procedure.
Event or Problem Description
Elegance study trial: it was reported that a thrombosis occurred after a stent was placed.The subject underwent treatment with two ranger paclitaxel-coated pta 6.0 mm x 200 mm and 6.0 mm x 100 mm balloon catheters on (b)(6) 2022 as a part of the elegance clinical trial.Target lesion was located in the right proximal, mid and distal superficial femoral artery with 100% stenosis and was 280mm long (diameter 6.0mm proximal and 5.0mm distal) and was classified as tasc ii d lesion.Prior to target lesion treatment, spiderfx embolization protection device was used and atherectomy was performed using jetstream xc followed by pre dilation with 5.0 mm x 220 mm sterling balloon and 5.0 mm x 200 mm vanguard iep pta balloon.During treatment of target lesion with the ranger balloon catheters thrombosis was observed.Atherectomy and aspiration was performed in response to the event, and the complication was resolved.The final residual stenosis was noted to be 0% and no thrombus was seen in the treated vessel at the end of the procedure.Additional information was reported that indicated the thrombosis was noted in the right mid superficial femoral artery prior to any intervention being performed in the target lesion (prior to index procedure) and was not related to the ranger device.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Common Device Name: 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: 14160963
• Report Number: 2134265-2022-03796
• Device Sequence Number: 17581436
• Product Code: ONU
• UDI-Device Identifier: 08714729976141
• UDI-Public: 08714729976141
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Report Date (Section B): 06/23/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 07624H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: Black Or African American