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

Model Number	H74939419502010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vasoconstriction (2126); Obstruction/Occlusion (2422)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that arterial flow to slow occurred.The stenosed target lesion was located in the calcified superficial femoral artery.A 5.0 x 200mm, 150cm ranger drug eluting peripheral balloon was selected for use.During the procedure, after treating a vessel, dye injection is performed to assess blood flow speed.At times, post-treatment blood flow appears slower.This slow flow is typically observed throughout the vessel proximal to, within, and distal to the lesion.The phenomenon was noticed following the removal of the balloon.The procedure was completed with the original device.There were no further patient complications reported.
Additional Manufacturer Narrative
H6 patient codes: corrected to vasoconstriction h6 impact codes: corrected to no health consequences or impact.
Event or Problem Description
It was reported that arterial flow to slow occurred.The stenosed target lesion was located in the calcified superficial femoral artery.A 5.0 x 200mm, 150cm ranger drug eluting peripheral ballon was selected for use.During the procedure, after treating a vessel, dye injection is performed to assess blood flow speed.At times, post-treatment blood flow appears slower.This slow flow is typically observed throughout the vessel proximal to, within, and distal to the lesion.The phenomenon was noticed following the removal of the balloon.The procedure was completed with the original device.There were no further patient complications reported.It was further reported that there are generally comorbidities present and the usual medications given are heparin, versed and fentanyl.

• 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: 20989484
• Report Number: 2124215-2024-80046
• Device Sequence Number: 15410016
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: 08714729976042
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2026
• Device Model Number: H74939419502010
• Device Catalogue Number: H74939419502010
• Device Lot Number: 08282H24
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 01/23/2025
• Date Device Manufactured: 08/13/2024
• 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
• Patient Sex: Unknown