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 Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a solent proxi thrombectomy system with no other devices.The pump, shaft, and tip were microscopically and visually examined and there was a kink in the supply line 118cm and 97cm from the power pulse adapter.Functional testing was performed by placing the device in the console.Functional testing showed a leak at the male connector with female luer.It was also observed that fluid was leaking from the boot.Fluid leaking from the connector is an 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 an error message occurred during aspiration.An angiojet® solent¿ proxi catheter was selected for a thrombectomy procedure.During aspiration, while the device was inside the patient, there was an error message.The catheter was removed and the procedure was completed with a different device.There were no reported patient complications.

• 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: 6401455
• MDR Text Key: 69845400
• Report Number: 2134265-2017-02159
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 109676-001
• Device Lot Number: 20046562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1