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

Model Number 1584-01

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

Patient Problems Pulmonary Edema (2020); Vasoconstriction (2126); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 04/06/2021

Event Type  Injury  

Event Description

It was reported that thrombosis occurred.An angioplasty was performed on a patient with an occlusion located in the posterior tibial artery (pt).A non boston scientific (bsc) plain balloon followed by a 3.00mm x 80mm, 150cm ranger sl drug coated balloon (dcb) was used for treatment.The patient appeared to have a spasm, glyceryl trinitrate (gtn) was administered, and after the digital subtraction angiography (dsa), there appeared to be limited flow in the posterior tibial (pt) and the anterior tibial (at) arteries.The clot was removed with a non bsc catheter and a tissue plasminogen activator was administered.There was flow in the pt artery after a few attempts to remove the clot with the catheter.The procedure was successfully completed and the patient was expected to fully recover.No further patient complications were reported in relation to this event.It was further reported that the foot of the patient improved and the patient has reported less pain than prior to the procedure.The physician is happy with the healing of the foot.The patient has had pulmonary edema since being in recovery, after the procedure, and was still in the hospital.No further patient complications were reported in relation to this event.

• Brand Name: RANGER SL
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11757790
• MDR Text Key: 248685294
• Report Number: 2134265-2021-05359
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2021

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
• Device Expiration Date: 09/03/2022
• Device Model Number: 1584-01
• Device Catalogue Number: 1584-01
• Device Lot Number: 05937H20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• 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
• Patient Outcome(s): Required Intervention