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

Model Number	H74939419600610
Medical Device Problem Codes	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
Event or Problem Description
It was reported that balloon deflation problem occurred, and additional intervention was performed.The target lesion was located in the popliteal artery.A 6.0 x 60mm, 135cm ranger balloon catheter was advanced for dilation.During the procedure, the hub of the balloon came off the catheter.The physician began to pin pull the balloon while it was still inflated.The physician tried to slide the hub back on and deflate the balloon but was unsuccessful.A wire and balloon were then placed alongside the inflated ranger to deflate it but was also unsuccessful.The balloon was brought back to the opening of the sheath and a wire was placed in the sheath to try and pop the balloon but was again unsuccessful.The sheath and the inflated balloon were then brought back to the access site.Using ultrasound, the inflated balloon was located in the artery and was punctured through the skin with the needle that was used to give local sedation.The device was removed from the patient and the procedure was completed using an alternate method.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the ranger device was returned for analysis.Upon inspection, it was observed that the shaft was detached 1mm from the distal end of the hub.Additionally, multiple kinks were identified along the length of the shaft.Visual examination of the returned device revealed that the balloon had been inflated but was not refolded post-inflation.The exact timing of when the balloon was subjected to positive pressure is unknown.No defects were noted in the balloon itself.The investigator reported being unable to inflate the balloon due to the detachment of the shaft.Both the markerbands and the tip section of the device were examined visually, and no abnormalities were found in either component.
Event or Problem Description
It was reported that balloon deflation problem occurred, and additional intervention was performed.The target lesion was located in the popliteal artery.A 6.0 x 60mm, 135cm ranger balloon catheter was advanced for dilation.During the procedure, the hub of the balloon came off the catheter.The physician began to pin pull the balloon while it was still inflated.The physician tried to slide the hub back on and deflate the balloon but was unsuccessful.A wire and balloon were then placed alongside the inflated ranger to deflate it but was also unsuccessful.The balloon was brought back to the opening of the sheath and a wire was placed in the sheath to try and pop the balloon but was again unsuccessful.The sheath and the inflated balloon were then brought back to the access site.Using ultrasound, the inflated balloon was located in the artery and was punctured through the skin with the needle that was used to give local sedation.The device was removed from the patient and the procedure was completed using an alternate method.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: 21827267
• Report Number: 2124215-2025-22566
• Device Sequence Number: 11834385
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: Black Or African American