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

Model Number	H74939419700410
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon would not deflate, resulting in puncture of the balloon with a needle.The target lesion was located in the mildly tortuous and mildly calcified arteriovenous fistula in the arm.A 7.0 x 40 mm, 135 cm ranger drug-coated balloon was selected for use.During the procedure, it was noted that the balloon would not deflate.The physician ultimately punctured the balloon directly using a needle.The procedure was completed with a different device.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the ranger device was returned to our post market quality assurance laboratory.The device was received with the guidewire inserted in the device.A visual and tactile examination of the shaft identified shaft damage 440mm distal from the distal end of the strain relief.A visual examination identified that the balloon section was pulled in a distal direction revealing the proximal markerband and was also noted to be severely creased.Positive pressure was applied when di water was observed to be leaking from the location to where the shaft was noted to be damaged.The balloon was unable to be inflated due to the damage noted to the shaft and the balloon.As per ifu the rated burst pressure for this device is 14 atmospheres.The tip section of the device was visually examined, and no issues were noted.This concludes the product analysis.
Event or Problem Description
It was reported that the balloon would not deflate, resulting in puncture of the balloon with a needle.The target lesion was located in the mildly tortuous and mildly calcified arteriovenous fistula in the arm.A 7.0 x 40mm, 135cm ranger drug-coated balloon was selected for use.During the procedure, it was noted that the balloon would not deflate.The physician ultimately punctured the balloon directly using a needle.The procedure was completed with a different device.There were no patient complications.
Additional Manufacturer Narrative
Investigation results: device evaluated by mfr: the ranger (dcb) was returned to our post market quality assurance laboratory with the guidewire inserted.A visual and tactile examination of the shaft identified shaft damage 440mm distal from the distal end of the strain relief and the balloon was separated in a complete balloon circumferential tear located approximately 47mm proximal of the distal tip.The balloon section was noted to be pulled in a distal direction revealing the proximal markerband, and was also noted to be severely creased.Positive pressure was applied when di water was observed to be leaking from the location to where the shaft was noted to be damaged.The balloon was unable to be inflated due to the damage noted to the shaft and the balloon.As per ifu the rated burst pressure for this device is 14 atmospheres.The tip section of the device was visually examined, and no issues were noted.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 was completed and confirmed that the event of failure to deflate was defined in the risk 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 'adverse event related to procedure.
Event or Problem Description
It was reported that the balloon would not deflate, resulting in puncture of the balloon with a needle.The target lesion was located in the mildly tortuous and mildly calcified arteriovenous fistula in the arm.A 7.0 x 40mm, 135cm ranger drug-coated balloon was selected for use.During the procedure, it was noted that the balloon would not deflate.The physician ultimately punctured the balloon directly using a needle.The procedure was completed with a different device.There were no patient complications.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22543473
• Report Number: 2124215-2025-46106
• Device Sequence Number: 17946487
• Product Code: ONU
• UDI-Device Identifier: 08714729976240
• UDI-Public: (01)08714729976240(17)270128(10)972H25
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 03/31/2026

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 Model Number: H74939419700410
• Device Catalogue Number: H74939419700410
• Device Lot Number: 00972H25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 03/04/2026
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/02/2025; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown