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

Model Number 109676-007

Device Problems Fluid/Blood Leak (1250); Failure to Prime (1492); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The pump, effluent/supply line, shaft and tip were microscopically, tactile and visually inspected.Inspection of the device numerous kinks throughout the catheter portion of the device.Functional testing was performed by placing the device in the angiojet console.The complaint device failed to complete the prime cycle and the ¿check saline¿ error was displayed on the console.No fluid was leaking from the pump area; however, there as a leak at the kink in the proximal shaft 49.5cm from the strain relief.The proximal shaft was microscopically inspected and it was found that there was a hole in the proximal shaft on the kink.The boot was removed to check the seal cap.The seal cap was torqued down completely.The seal cap was removed by unscrewing it and removing it from the pump.The high pressure seal and low pressure seal (silicone ring) were removed.Neither was damaged and were placed back into the pump.The seal cap was replaced and tightened down until tight.Functional testing was performed once again by placing the device into the angiojet console.Functional testing was started but the check saline error displayed on the console again.It was determined that the kink at the hole in the shaft was significant enough to cause an over pressure not allowing enough pressure to flow through the device, causing it not to run and alarm.Inspection of the remainder of the device presented no other damage or irregularities.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 22-sep-2017.It was reported that the catheter would not prime, there was a check saline supply message and the pump was leaking.An angiojet® solent¿ proxi catheter was selected for a procedure in the iliac vein.During preparation, the catheter could not complete the prime.The system alerted with "please check the saline".The physician reset the system several times, however the catheter could not complete the prime.The system alerted with "please change the catheter".There was saline leaking under the pump.There were no visible defects on the catheter or console.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was reported as stable.However, device analysis revealed a hole in the proximal shaft of the catheter.

• 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: 6952380
• MDR Text Key: 90404384
• Report Number: 2134265-2017-09877
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K101406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2017

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: 08/20/2017
• Device Model Number: 109676-007
• Device Lot Number: 0000194496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2015
• 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