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

Model Number	H74939419602010
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The returned device was attached to a boston scientific encore inflation unit and the balloon was inflated to its rated burst pressure of 14 atm and a pinhole leak was noted 12mm proximal from the distal tip.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 hypotube shaft found no issues with the shaft.This concludes the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 26nov2024.It was reported that the balloon issues occurred.The 100% stenosed target lesion was located in the non-tortuous and mildly calcified vessel in the lower extremity.A 6.0 x 200mm, 150cm ranger drug-coated balloon was selected for angiogram.However, during the procedure, it was noted that the balloon was leaking and losing pressure once inflated to 6 atmospheres.The procedure was completed using an alternate device.No patient complications were reported.However, device analysis revealed a pinhole leak at 12mm proximal from the distal tip.

• 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: 20863275
• Report Number: 2124215-2024-75729
• Device Sequence Number: 15594722
• Product Code: ONU
• UDI-Device Identifier: 08714729976202
• UDI-Public: 08714729976202
• Combination Product (Y/N): Y
• Initial Reporter State: SD
• 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
• Report Date (Section B): 12/06/2024

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: 04/23/2026
• Device Model Number: H74939419602010
• Device Catalogue Number: H74939419602010
• Device Lot Number: 03794H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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