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); Material Deformation (2976)

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

Event Date 04/18/2023

Event Type  malfunction  

Event Description

It was reported that the balloon catheter became entrapped on the guidewire.This ranger paclitaxel-coated pta balloon catheter 6.0 x 200mm, 150cm was selected for use in an endovascular therapy procedure.The lesion was in the superficial femoral artery (sfa), was moderately calcified, had moderate tortuosity, and was 100% stenosed.When the guidewire was pushed into the contralateral guiding sheath, it got kinked together and stuck with the shaft of the balloon catheter and was subsequently unable to be advanced.The balloon and guidewire were removed as one unit, and once outside the body, the guidewire was able to be removed from the catheter.The procedure was completed with another of the same device.There was no patient injury.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16932605
• MDR Text Key: 315243952
• Report Number: 2124215-2023-18922
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976202
• UDI-Public: 08714729976202
• 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: 05/15/2023

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: 06048H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• 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
• Treatment: GUIDEWIRE: CRUISE.; INTRODUCER SHEATH: PARENT PLUS 6F.