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

Model Number	H74939419600610
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	07/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deflation issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.A 6.0 x 60mm, 135cm ranger balloon catheter was advanced for dilation.The balloon was inflated once for 3 minutes.During removal, it was noted that the balloon would not deflate.A wire was used to pierce and tear the balloon, thus draining the solution inside the balloon, deflate it and removing it.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that deflation issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.A 6.0 x 60mm, 135cm ranger balloon catheter was advanced for dilation.The balloon was inflated once for 3 minutes.During removal, it was noted that the balloon would not deflate.A wire was used to pierce and tear the balloon, thus draining the solution inside the balloon, deflate it and removing it.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured approximately 4mm in length and extended from a position 2mm proximal of the distal markerband to 1mm distal of the distal markerband.As per ifu the rated burst pressure for this device is 14 atmospheres.The markerbands and tip section of the device were visually examined, and no issues were noted with the markerbands or tip of the device.A visual and tactile examination of the shaft identified multiple kinks.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured approximately 4mm in length and extended from a position 2mm proximal of the distal markerband to 1mm distal of the distal markerband.As per ifu the rated burst pressure for this device is 14 atmospheres.The markerbands and tip section of the device were visually examined, and no issues were noted with the markerbands or tip of the device.A visual and tactile examination of the shaft identified multiple kinks.Measurements of the exact locations of the kinks on the shaft are as follows: kink 1.270mm distal from the distal end of the strain relief.Kink 2.285mm distal from the distal end of the strain relief.Kink 3.289mm distal from the distal end of the strain relief.Kink 4.338mm distal from the distal end of the strain relief.Kink 5.350mm distal from the distal end of the strain relief.Kink 6.810mm distal from the distal end of the strain relief.Kink 7.15mm proximal from the distal tip.No other issues were identified with the device.
Event or Problem Description
It was reported that deflation issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.A 6.0 x 60mm, 135cm ranger balloon catheter was advanced for dilation.The balloon was inflated once for 3 minutes.During removal, it was noted that the balloon would not deflate.A wire was used to pierce and tear the balloon, thus draining the solution inside the balloon, deflate it and removing it.There were no patient complications as a result of this event.

• 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: 22686341
• Report Number: 2124215-2025-50381
• Device Sequence Number: 18392426
• Product Code: ONU
• UDI-Device Identifier: 08714729976103
• UDI-Public: (01)08714729976103(17)261025(10)11146H24
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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: H74939419600610
• Device Catalogue Number: H74939419600610
• Device Lot Number: 11146H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/22/2025; 09/23/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/18/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown