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

Model Number	H74939419700410
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon was ruptured and embolism occurred, requiring intervention.The target lesion was located in a moderately tortuous and moderately calcified vessel.A 7.0 x 40mm, 135cm ranger balloon catheter was selected for use.The balloon was successfully inflated for the first time then repositioned.During the second inflation, however, the balloon ruptured at 10 atmospheres.It was determined that a balloon fragment detached in the vessel.Snaring was attempted to retrieve the detached fragment, but the attempts were unsuccessful.The fragment embolized in a small collateral vein.The embolized fragment was estimated to have no negative impact on the patient, and the patient was fully recovered.
Additional Manufacturer Narrative
Investigation results: 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.Device technical analysis: the device was not received for analysis, as it was discarded by the healthcare facility; therefore, product analysis could not be performed.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.Thromboembolic episodes is included in the list of potential adverse events associated with the use of this device.Risk review: a risk review performed for the ranger (dcb) device confirmed that the event of balloon material rupture, balloon detachment of device or device component, unretrieved device fragments (udf), embolism and additional device required are known events defined in the products risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion code: boston scientific concludes the most probable root cause as adverse event related to procedure.Procedural factors such as patient anatomy and lesion characteristics likely contributed to the balloon rupture and subsequent balloon material separation during lesion treatment.The unretrieved balloon fragment and the need for an additional device occurred during attempts to remove the separated material.
Event or Problem Description
It was reported that the balloon was ruptured and embolism occurred, requiring intervention.The target lesion was located in a moderately tortuous and moderately calcified vessel.A 7.0 x 40mm, 135cm ranger balloon catheter was selected for use.The balloon was successfully inflated for the first time then repositioned.During the second inflation, however, the balloon ruptured at 10 atmospheres.It was determined that a balloon fragment detached in the vessel.Snaring was attempted to retrieve the detached fragment, but the attempts were unsuccessful.The fragment embolized in a small collateral vein.The embolized fragment was estimated to have no negative impact on the patient, and the patient was fully recovered.

• 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: 24332644
• Report Number: 2124215-2026-08213
• Device Sequence Number: 15900437
• Product Code: ONU
• UDI-Device Identifier: 08714729976240
• UDI-Public: (01)08714729976240(17)280824(10)9143H25
• 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
• Report Date (Section B): 03/17/2026

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: 09143H25
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/17/2026
• Date Device Manufactured: 08/25/2025
• 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; Other
• Patient Sex: Unknown