MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS

Model Number 1177-01

Device Problems Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/17/2024

Event Type  malfunction  

Event Description

It was reported that the balloon was stuck with the wire.The target lesion was located in the common femoral artery.A 6.0mm x 80mm, 135cm ranger drug-coated balloon catheter was advanced for dilatation.The balloon was normally flushed, but then it became stuck with the guidewire.The guidewire and catheter were withdrawn together, and the device was entangled when outside the patient.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis and was received loaded on to the customer's guidewire.As per instructions for use (ifu), this device is compatible with 0.014 in and 0.018 in guidewires.The outer diameter of the guidewire was measured and confirmed to be 0.018".A visual examination found the outer polymer coating of the guidewire to be severely damaged/buckled.During product analysis the investigator was unable to remove the customers guidewire from the device due to damage/buckling to the guidewire.A visual and tactile examination found the shaft of the device to be severely stretched/buckled at more than one location.This type of damage is consistent with excessive force being applied to the delivery system.A visual examination of the balloon, tip and markerbands found no issues.

Event Description

It was reported that the balloon was stuck with the wire.The target lesion was located in the common femoral artery.A 6.0mm x 80mm, 135cm ranger drug-coated balloon catheter was advanced for dilatation.The balloon was normally flushed, but then it became stuck with the guidewire.The guidewire and catheter were withdrawn together, and the device was entangled when outside the patient.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19025801
• MDR Text Key: 339218972
• Report Number: 2124215-2024-18327
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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
• Device Operator: Health Professional
• Device Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Device Lot Number: 00393H23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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
• Treatment: GUIDEWIRE: VICTORY; GUIDEWIRE: VICTORY
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 70 KG