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

Model Number	H74939419600610
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported via medwatch report # mw5168059 that additional intervention was required to remove a partially deflated balloon.A 6.0 x 60 mm, 135 cm ranger drug- coated balloon (dcb) was selected for use in a percutaneous transluminal angioplasty of the distal superficial femoral artery (sfa) and popliteal artery.The target lesion was 85% stenosed, mildly tortuous, non-calcified.Moderately fibrotic plaque was present.A 5f sheath was placed up and over into the contralateral sfa.The ranger (dcb) was dilated for 3 minutes.Upon removal, the hub detached from the catheter.As a result, the balloon remained slightly inflated.Attempts were made to compress the balloon which included using a buddy wire and placing balloon next to the ranger (dcb).Eventually, the 5f sheath and partially deflated ranger (dcb) were brought all the way back to the left common femoral artery (cfa).Under ultrasound guidance, a micropuncture needle was used to pop the balloon which allowed it to be delivered to the sheath and removed over a.018 guidewire that was still in place.All devices were removed.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: 21930343
• Report Number: 2124215-2025-26694
• Device Sequence Number: 15721679
• Product Code: ONU
• UDI-Device Identifier: 08714729976103
• UDI-Public: (01)08714729976103(17)260604(10)5314H24
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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 Expiration Date: 06/04/2026
• Device Model Number: H74939419600610
• Device Catalogue Number: H74939419600610
• Device Lot Number: 05314H24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/29/2025
• Date Device Manufactured: 06/04/2024
• 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