MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Ranger Paclitaxel-Coated PTA Balloon Catheter; Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Model Number	1973-03
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion with straight geometry was located in the moderately tortuous and mildly calcified superficial femoral artery.Following pre-dilatation, a 5.0x 60mm, 80cm ranger paclitaxel-coated pta balloon catheter was advanced through the sheath with a loading tool.However, during the initial inflation, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient was in good condition post-procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion with straight geometry was located in the moderately tortuous and mildly calcified superficial femoral artery.Following pre-dilatation, a 5.0x 60mm, 80cm ranger paclitaxel-coated pta balloon catheter was advanced through the sheath with a loading tool.However, during the initial inflation, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
Investigation results: device history record: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.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.Risk review: a risk review performed for the ranger paclitaxel-coated pta balloon 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 benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to patient condition.

• Brand Name: Ranger Paclitaxel-Coated PTA Balloon Catheter
• 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 ; +1(612)875-7234
• MDR Report Key: 18703918
• Report Number: 2124215-2024-08170
• Device Sequence Number: 17991019
• Product Code: ONU
• UDI-Device Identifier: 08714729975953
• UDI-Public: 08714729975953
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 01/29/2025
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 00860H23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• 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