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

Model Number	H74939419502010
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft hole occurred.The 85% stenosed target lesion was located in the non-tortuous and non-calcified superficial femoral artery restenosis.A 5.0 x 200mm, 150cm ranger drug-coated balloon catheter was advanced for dilation.However, a leak was noted to be caused by the back end of the v-18 guidewire perforating the inflation lumen from the wire lumen while being passed over the wire when reinserted for subsequent inflations.
Additional Manufacturer Narrative
H6 - device codes: added code for fluid/blood leak.H6 - evaluation method codes: added b14 and b17.H6 - evaluation conclusion codes: updated to unintended use error caused or contributed to event.Investigation results: device history record (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 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 unintended use error caused or contributed to event.
Event or Problem Description
It was reported that shaft hole occurred.The 85% stenosed target lesion was located in the non-tortuous and non-calcified superficial femoral artery restenosis.A 5.0 x 200mm, 150cm ranger drug-coated balloon catheter was advanced for dilation.However, a leak was noted to be caused by the back end of the v-18 guidewire perforating the inflation lumen from the wire lumen while being passed over the wire when reinserted for subsequent inflations.

• 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: 21598638
• Report Number: 2124215-2025-13252
• Device Sequence Number: 15684579
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: 08714729976042
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Report Date (Section B): 04/14/2026

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 Expiration Date: 06/10/2026
• Device Model Number: H74939419502010
• Device Catalogue Number: H74939419502010
• Device Lot Number: 05555H24
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 06/10/2024
• 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
• Patient Sex: Unknown