MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT PROXI; CATHETER, CONTINUOUS FLUSH

Model Number 45032

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems Renal Failure (2041); Dysuria (2684)

Event Date 05/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the patient experienced acute renal failure and decreased urine output that was treated with dialysis.An angiojet solent proxi was selected for a patient thrombectomy procedure.The lesion was not calcified.The patient was considered healthy with no co-morbidities and the pre-procedure creatinine level was normal.She was given pre-hydration.During the procedure, two "check saline supply" error messages occurred, but the procedure was still able to be completed with that device.Power pulse with urokinase (300000ui/100cc of saline) was used, and the thrombectomy run time was 170sec.A small amount of contrast was used.No patient complications occurred during the procedure.The patient condition after the procedure was stable.After the vesical catheterization the patient was transferred to the surgery room with 1.5 liters of clear urine and saline hydration.However, two days after the procedure the patient's creatinine increased to 14mg/dl and her urine output was less than 50cc/day.The physician treated the acute renal failure with medications and dialysis, and the patient ended up needing a prolonged hospital stay.Two weeks later, the patient status was improving, but she was still under dialysis in the hospital with a urine output of 200cc/day and a creatinine level that had not yet returned to normal.The patient has since been discharged home and is okay.She is not expected to have any further repercussions.The physician believes that the acute renal failure was due to thrombectomy with angiojet.

• Brand Name: ANGIOJET SOLENT PROXI
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8748287
• MDR Text Key: 149641782
• Report Number: 2134265-2019-07548
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K101406
• 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: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2019
• Device Model Number: 45032
• Device Catalogue Number: 45032
• Device Lot Number: 0021443306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 21 YR