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

Lot Number	10897H25
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that partial dissection occurred requiring additional intervention.A 6.0 x 200 mm 200cm ranger drug-coated balloon catheter was selected for use.During the procedure, the sheath had been inserted at a slightly right angle.Although the balloon crossed without difficulty, the ranger could not pass through the sheath and was slowly withdrawn together with the sheath (with the sheath left in place).The second 6.0 x 200 mm 200cm ranger drug-coated balloon catheter was also quite tight but was eventually delivered.Consequently, a partial dissection was noted after the removal of the 2nd ranger drug-coated balloon catheter.As a result, a non-boston scientific stent was placed as a bailout.After the procedure, the sheath was checked and no kinking or other abnormalities were observed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: the device was not received for analysis despite multiple inquiries regarding return status.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the ranger dcb device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported that partial dissection occurred requiring additional intervention.A 6.0 x 200 mm 200cm ranger drug-coated balloon catheter was selected for use.During the procedure, the sheath had been inserted at a slightly right angle.Although the balloon crossed without difficulty, the ranger could not pass through the sheath and was slowly withdrawn together with the sheath (with the sheath left in place).The second 6.0 x 200 mm 200cm ranger drug-coated balloon catheter was also quite tight but was eventually delivered.Consequently, a partial dissection was noted after the removal of the 2nd ranger drug-coated balloon catheter.As a result, a non-boston scientific stent was placed as a bailout.After the procedure, the sheath was checked and no kinking or other abnormalities were observed.There were no patient complications as a result of this event.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• 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): FREUDENBERG MEDICAL; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24552616
• Report Number: 2124215-2026-12998
• Device Sequence Number: 9404614
• Product Code: ONU
• UDI-Device Identifier: 00191506046811
• UDI-Public: (01)00191506046811(17)271007(10)10897H25
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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
• Operator of Device: Health Professional
• Device Lot Number: 10897H25
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 10/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH - TERUMO 6F INTRODUCER; INTRODUCER SHEATH - TERUMO 6F INTRODUCER; STENT - SMART; STENT - SMART
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown