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

Model Number	H74939419502010
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that wire broke through balloon material occurred.The 80% stenosed, 200mm target lesion was located in the moderately tortuous and moderately calcified peripheral artery.A 5.0 x 200mm, 150cm ranger (dcb) drug-eluting peripheral transluminal angioplasty catheter and a v-18 control wire were selected for use.Pre-dilatation was performed prior to use of the balloon.During the procedure, it was noted that the wire broke and coming out through the balloon.The procedure was completed using an alternate device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that wire broke through balloon material occurred.The 80% stenosed, 200mm target lesion was located in the moderately tortuous and moderately calcified peripheral artery.A 5.0 x 200mm, 150cm ranger (dcb) drug-eluting peripheral transluminal angioplasty catheter and a v-18 control wire were selected for use.Pre-dilatation was performed prior to use of the balloon.During the procedure, it was noted that the wire broke and coming out through the balloon.The procedure was completed using an alternate device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the ranger device was returned for analysis.A visual examination identified that the balloon was tightly folded which indicates that the device was subjected not subjected to positive pressure.The balloon was noted to be twisted at the centre.A leak test was carried out using de-ionized water when liquid was observed exiting from the tip of the device.An examination of the balloon material found no issues.The loading tool was not present on device.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found the shaft of the device to be kinked at the same location as the balloon twist.A leak test was carried out to identify the location of where the guidewire exited the device.Liquid was observed exiting the tip of the device which is an indication of a breach between the wire lumen and the inflation lumen.It is most probable that the location of the lumen breach is where the shaft is kinked.No other issues were identified with the shaft.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and in the correct position on the shaft of the device.No other issues were identified with the device.
Event or Problem Description
It was reported that wire broke through balloon material occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified peripheral artery.A 5.0 x 200mm, 150cm ranger (dcb) drug-eluting peripheral transluminal angioplasty catheter was selected for use.Pre-dilatation performed prior to use the balloon.However, the wire broke the balloon during mounting during procedure.A v-18 wire was used as a loading tool when advancing through the sheath.The procedure was completed using an alternate device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H6 - evaluation result codes: updated device evaluated by mfr: the ranger device was returned for analysis.A visual examination identified that the balloon was tightly folded which indicates that the device was subjected not subjected to positive pressure.The balloon was noted to be twisted at the centre.A leak test was carried out using de-ionized water when liquid was observed exiting from the tip of the device.An examination of the balloon material found no issues.The loading tool was not present on device.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found the shaft of the device to be kinked at the same location as the balloon twist.A leak test was carried out to identify the location of where the guidewire exited the device.Liquid was observed exiting the tip of the device which is an indication of a breach between the wire lumen and the inflation lumen.It is most probable that the location of the lumen breach is where the shaft is kinked.No other issues were identified with the shaft.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and in the correct position on the shaft of the device.No other issues were identified with the device.

• 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: 22702193
• Report Number: 2124215-2025-51666
• Device Sequence Number: 15740784
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: (01)08714729976042(17)261202(10)12566H24
• Combination Product (Y/N): Y
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2025

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: Health Professional
• Device Model Number: H74939419502010
• Device Catalogue Number: H74939419502010
• Device Lot Number: 12566H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 11/10/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 10/02/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 76 KG