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

Model Number	H74939419501510
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).
Event or Problem Description
It was reported that foreign object was noted in the device's packaging.The target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 5.0 x 150mm, 150cm ranger global dcb balloon catheter was selected for use in the procedure.During procedure outside patient, a human hair was found in the final packaging.The device was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the ranger global was returned for analysis.The device was returned within the protective hoop and enclosed in the outer box carton.It had been taken out of the inner pouch of the packaging.A surgical glove, which was turned inside out likely during removal from the hand was also returned with the device.Upon examining the inside of the glove, a black fiber approximately 75mm in length was discovered.At this time, it is not possible to ascertain the origin or composition of the fiber.There is no evidence to indicate that the fiber originated from either the device or its packaging.
Event or Problem Description
It was reported that foreign object was noted in the device's packaging.The target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 5.0 x 150mm, 150cm ranger global dcb balloon catheter was used in the procedure.During procedure outside patient, a human hair was found in the final packaging.The device was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Investigation results: device evaluated by mfr: the 5.0 x 150mm, 150cm ranger global dcb device was returned to our post market quality assurance laboratory.Device result.Upon examining the inside of the glove, a black fiber approximately 75mm in length was discovered.At this time, it is not possible to ascertain the origin or composition of the fiber.There is no evidence to indicate that the fiber originated from either the device or its packaging.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.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 global dcb 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 unintended use error caused or contributed to event.
Event or Problem Description
It was reported that foreign object was noted in the device's packaging.The target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 5.0 x 150mm, 150cm ranger global dcb balloon catheter was used in the procedure.During procedure outside patient, a human hair was found in the final packaging.The device was completed with another of the same device.No patient complications were reported.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21360218
• Report Number: 2124215-2025-07497
• Device Sequence Number: 15562910
• Product Code: ONU
• UDI-Device Identifier: 08714729976028
• UDI-Public: 08714729976028
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2026

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: 01/18/2026
• Device Model Number: H74939419501510
• Device Catalogue Number: H74939419501510
• Device Lot Number: 00424H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/19/2025; 03/19/2026
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/18/2025; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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