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

Model Number	H74939419700410
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via a good laboratory practice (glp) study that sterility was compromised due to damaged device packaging.One 7.0 x 40mm, 135cm ranger drug-coated balloon (dcb) was removed from the commercial labeled box to introduce to an animal subject.Upon removal and prior to use, however, it was observed that the inner package was punched, making the device unsterile and unusable.After this observation, the rest of the remaining unused ranger dcbs were inspected prior to use.In addition to the first ranger dcb, four more ranger dcbs were also identified to have damaged inner packaging.There were 3 from lot 2440h24 and 2 from lot 04347h24.The devices were not used in the glp study.

• 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: 22106953
• Report Number: 2124215-2025-29290
• Device Sequence Number: 8139601
• Product Code: ONU
• UDI-Device Identifier: 08714729976240
• UDI-Public: (01)08714729976240(17)260503(10)4347H24
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2025

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: Other
• Device Expiration Date: 05/03/2026
• Device Model Number: H74939419700410
• Device Catalogue Number: H74939419700410
• Device Lot Number: 04347H24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/29/2025
• Date Device Manufactured: 05/03/2024
• 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