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

Model Number 1177-01

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/27/2023

Event Type  malfunction  

Event Description

It was reported that device separation occurred.A 5x150mm, 150cm ranger drug coated balloon was selected for a procedure.The balloon was inserted into a 6 french sheath; however, it became stuck in the sheath.Then the physician tried removing the balloon from the patient, the device came apart in two pieces, the catheter and the balloon.Both of the pieces were removed from the patient.There were no patient complications reported.

Manufacturer Narrative

Device evaluation by manufacturer: returned product consisted of a ranger drug coated balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the guidewire lumen is separated 50.1cm from the tip.The inflation lumen is separated 53cm from the tip.There are multiple kinks along the shaft.The inflation lumen and guidewire lumen is stretched.Microscopic examination revealed no additional damages.The hub, proximal end of the inflation lumen and guidewire lumen are missing.

Event Description

It was reported that device separation occurred.A 5x150mm, 150cm ranger drug coated balloon was selected for a procedure.The balloon was inserted into a 6 french sheath; however, it became stuck in the sheath.Then the physician tried removing the balloon from the patient, the device came apart in two pieces, the catheter and the balloon.Both of the pieces were removed from the patient.There were no patient complications reported.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 18220340
• MDR Text Key: 329353036
• Report Number: 2124215-2023-65849
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

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: 04664H23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1