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

Model Number 1973-03

Device Problems Entrapment of Device (1212); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  malfunction  

Event Description

It was reported that the ranger and guidewire became stuck.A ranger 5.0mm x 200mm, 150cm was selected for use in a superficial femoral artery (sfa) atherectomy procedure for endovascular therapy for peripheral artery disease.The target lesion had 90 percent stenosis with moderate calcification and severe tortuosity.Pre-inflation was performed using a 0.035 jupiter and mustang 5mmx100mm to apply this ranger to the opposite distal sfa; however, the ranger was unable to cross the lesion.The guidewire was replaced with chevalier floppy 0.014 guidewire and this ranger balloon was taken, but still not advancing well due to difficult anatomy of the iliac.The physician persisted and tried to advance, but the ranger got stuck with the guidewire and could no longer be used.The procedure was completed using another device without sequelae.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: 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: 18012512
• MDR Text Key: 326626654
• Report Number: 2124215-2023-59696
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: 08714729976042
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2023

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
• Device Operator: Health Professional
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 03869H23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1