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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Pseudoaneurysm (2605)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

A2 patient age: 67 years old at time of procedure.B3: date of event is estimated as it was not known.

Event Description

Literature case study paclitaxel popliteal pseudoaneurysm.It was reported that the patient developed pseudoaneurysm post treatment with this device, requiring an additional device.This 4.0 x 60mm ranger paclitaxel-coated pta balloon catheter was selected for use in an endovascular therapy (evt) procedure to treat a right popliteal artery occlusion.During the index procedure, a 6-fr sheath was inserted into the right common femoral artery via the ipsilateral approach.Control angiography revealed an occlusion of the distal aspect of the popliteal artery.In addition, a linear contrast agent leakage was observed.A distal puncture was subsequently performed, and the occlusion was crossed via a retrograde approach with a 0.014 inch guidewire.After five minutes of inflation with 2.5mm balloon, the contrast agent leakage disappeared.Although subintimal wiring was detected by intravascular ultrasound (ivus), the wires could not cross the true lumen in the middle part of the lesion.Stent placement was not performed because of the lesion location, vessel size, and the reasonable angiographic result after the balloon angioplasty.The vessel diameter of the lesion was measured to be approximately 4mm by ivus, and additional dilation with this 4.0 x 60mm ranger paclitaxel-coated pta balloon catheter was performed.The final angiography revealed vessel dilation without contrast agent leakage.After evt, the residual pain disappeared.Three months post procedure, the patient presented with right knee pain and was subsequently hospitalized.Computed tomography was performed which revealed a right popliteal pseudoaneurysm.An evt procedure was therefore performed and ivus revealed a vessel wall defect at the site of the pseudoaneurysm.A stent graft was implanted, and post-balloon dilation was performed.Final angiography of the second evt revealed exclusion of the popliteal pseudoaneurysm.After stent graft implantation, the pain in the right knee improved.

• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18056476
• MDR Text Key: 327178024
• Report Number: 2124215-2023-58262
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2023
• Initial Date FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female