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

Lot Number	06035H25
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 6.0 x 200 mm 200cm ranger balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after the first inflation at 14 atmospheres for 15 seconds.The device was removed without any problem, and the procedure was completed with this device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 6.0 x 200 mm 200cm ranger balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after the first inflation at 14 atmospheres for 15 seconds.The device was removed without any problem, and the procedure was completed with this device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device was returned for analysis.Visual examination identified that the balloon was not folded, indicating that it had been subjected to positive pressure.A longitudinal tear was observed in the balloon material.The tear measured approximately 23 mm in length and extended from approximately 20 mm proximal to the distal marker band to 43 mm proximal to the distal marker band.According to the instructions for use (ifu), the rated burst pressure for this device is 14 atmospheres.The marker bands and distal tip section were visually examined, and no abnormalities were identified.Visual and tactile examination of the hypotube shaft revealed no issues.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 6.0 x 200 mm 200cm ranger balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after the first inflation at 14 atmospheres for 15 seconds.The device was removed without any problem, and the procedure was completed with this device.There were no patient complications as a result of this event.It was further reported that anatomically, the lesion was a chronic total occlusion and there were no particular factor that may have influenced this incident.
Additional Manufacturer Narrative
Investigation results: the device was returned for analysis.Visual examination revealed that the balloon was not folded, indicating that it had been subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured approximately 23 mm in length, extending from 20 mm proximal to the distal marker band to 43 mm proximal to the distal marker band.Per the instructions for use, the rated burst pressure for this device is 14 atmospheres.Visual inspection of the marker bands and tip section identified no abnormalities.Additionally, visual and tactile examination of the hypotube shaft revealed no issues.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that 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 risk review performed for the ranger 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 benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was adverse event related to patient condition.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 6.0 x 200 mm 200cm ranger balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after the first inflation at 14 atmospheres for 15 seconds.The device was removed without any problem, and the procedure was completed with this device.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): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23627621
• Report Number: 2124215-2025-85640
• Device Sequence Number: 16071569
• Product Code: ONU
• UDI-Device Identifier: 00191506046811
• UDI-Public: (01)00191506046811(17)270611(10)6035H25
• 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,Followup,Followup
• Report Date (Section B): 04/10/2026

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 Lot Number: 06035H25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 01/28/2026; 03/20/2026
• Initial Report FDA Received Date: 11/23/2025
• Supplement Report FDA Received Date: 02/04/2026; 02/19/2026; 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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
• Patient Sex: Unknown