MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ANGIOJET® SOLENT¿ PROXI; CATHETER, CONTINUOUS FLUSH

Model Number 109676-001

Device Problems Device Displays Incorrect Message (2591); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a solent proxi thrombectomy with a with no other devices.The pump, shaft, and tip were microscopically examined and there were no damage or irregularities.A functional testing was performed by placing the device in the console.Functional testing showed a leak at the male connector with female luer.Fluid leaking from the connector is in indication that the outlet adapter seal failed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause of the reported difficulty is a design constraint of the product.(b)(4).

Event Description

It was reported that there was an error message during aspiration.An angiojet® solent¿ proxi catheter was selected for a superficial femoral artery (sfa)/popliteal thrombectomy procedure.The console and catheter were prepared, priming was complete, and the catheter was advanced over the wire to the selected area for treatment.Thrombectomy was conducted for 42 seconds when the console stopped working with a message to check saline bag tubing and prime again.The catheter was removed from the patient.It was attempted to prime again, but only advanced to -12 seconds.The catheter was replaced with a different device and the procedure was completed successfully.There were no patient complications reported and the patient's status was stable.

• Brand Name: ANGIOJET® SOLENT¿ PROXI
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6436072
• MDR Text Key: 70987938
• Report Number: 2134265-2017-02447
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K101406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2017

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 Expiration Date: 10/31/2018
• Device Model Number: 109676-001
• Device Lot Number: 20079656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• 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 Age: 83 YR