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

Lot Number	04138H25
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 5% stenosed target lesion was located in the mildly tortuous and severely calcified right superficial femoral artery.A 6.0 x 60 mm 200cm ranger drug-coated balloon catheter was advanced for dilatation.During the initial inflation at 6 atmospheres for 1 minute, the balloon ruptured.The device was removed, and the procedure was completed.There were no procedural issues noted; however, the severe calcification presented anatomical characteristics that may have contributed to the event.No patient injury or complications were reported.
Event or Problem Description
It was reported that a balloon rupture occurred.The 5% stenosed target lesion was located in the mildly tortuous and severely calcified right superficial femoral artery.A 6.0 x 60 mm 200cm ranger drug-coated balloon catheter was advanced for dilatation.During the initial inflation at 6 atmospheres for 1 minute, the balloon ruptured.The device was removed, and the procedure was completed.There were no procedural issues noted; however, the severe calcification presented anatomical characteristics that may have contributed to the event.No patient injury or complications were reported.Investigation results: upon receipt at our post market quality assurance laboratory, this ranger (dcb) device was examined.A visual examination identified that the balloon had been subjected to positive pressure.A leak test identified a pinhole in the balloon material confirming the event.An examination of the tip and markerbands found no issues.No kinks or damage were noted along the shaft of the device.No other issues were identified during the product analysis.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 that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the ranger (dcb) device confirmed that the event of balloon material rupture is a known event defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as adverse event related to patient condition.
Additional Manufacturer Narrative
Investigation results: upon receipt at our post market quality assurance laboratory, this ranger (dcb) device was examined.A visual examination identified that the balloon had been subjected to positive pressure.A leak test identified a pinhole in the balloon material confirming the event.An examination of the tip and markerbands found no issues.No kinks or damage were noted along the shaft of the device.No other issues were identified during the product analysis.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 that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the ranger (dcb) device confirmed that the event of balloon material rupture is a known event defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as adverse event related to patient condition.

• 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: 24645794
• Report Number: 2124215-2026-15386
• Device Sequence Number: 13313788
• Product Code: ONU
• UDI-Device Identifier: 00191506046767
• UDI-Public: (01)00191506046767(17)270428(10)4138H25
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 04138H25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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