MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ANGIOJET®; CATHETER, EMBOLECTOMY

Model Number UNK872

Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a spiroflex thrombectomy system.The pump, effluent/supply line, shaft, tip, piston, and spike line were microscopically, tactile and visually inspected.There was a small amount of fluid in the boot when received.There were numerous kinks throughout the shaft of the device and in the spike line.Functional testing was performed by placing the device in the angiojet console.The pump body was loose in the capture block.Functional testing consisted of running the complaint device through the full priming cycle and 180 seconds in thrombectomy mode.The device ran within normal range without any issues or alarms/errors; however, there was a leak in the shaft.The shaft was inspected and it was revealed that 39cm distal of the strain relief, there was a hole in the pebax shaft.The piston head was manually rotated and ran through priming with issues or changes to the priming outcome.The od (outer diameter) of the piston rod (hex a) was measured and the dimension of the hex e was measured.Inspection of the device presented no other damage or irregularities.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Reportable based on device analysis completed on 11 apr 2018.It was reported an error message displayed and priming would not work properly.An spiroflex® angiojet® thrombectomy set was selected for a thrombectomy procedure.During preparation outside the patient, the catheter would only prime for a short period of time and a "check saline line" error message displayed.The device was continually checked; however still did not work.The procedure was completed with a different device.There were no patient complications.Device analysis found a hole in the shaft.

• Brand Name: ANGIOJET®
• Type of Device: CATHETER, EMBOLECTOMY
• 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: 7473421
• MDR Text Key: 106914999
• Report Number: 2134265-2018-03641
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2018

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: 10/14/2019
• Device Model Number: UNK872
• Device Lot Number: 21477750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2017
• 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