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

Model Number	H74939419401510
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device became stuck with the wire.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified right superficial femoral artery.A 4.0 x 150mm, 150cm ranger drug-coated balloon catheter was advanced for dilation.During the procedure, the device became stuck with the 0.018 non-boston scientific guidewire.Both devices were removed as a single unit, and eventually the wire was removed from the catheter outside the body.The procedure was completed with a different device.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination of the returned device found that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.No issues noted with the balloon.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 shaft found multiple kinks and the shaft was also noted to be accordioned.The investigator was unable to insert the guidewire through the device due to the damage to the shaft.No other issues were identified during the product analysis.

• 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: 20856373
• Report Number: 2124215-2024-74117
• Device Sequence Number: 4058418
• Product Code: ONU
• UDI-Device Identifier: 08714729975861
• UDI-Public: 08714729975861
• 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
• Report Date (Section B): 12/05/2024

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: 09/26/2025
• Device Model Number: H74939419401510
• Device Catalogue Number: H74939419401510
• Device Lot Number: 09046H23
• 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: 11/07/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: 0.018 COMMAND
• Patient Sex: Unknown