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

Model Number 105041-001

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that an error message displayed during the procedure.An angiojet® ultra xmi® thrombectomy set was selected for a thrombectomy procedure.During use inside the patient, a check saline supply error message displayed.The device was removed from the patient's body and re-priming was attempted.The device would not re-prime.The procedure was completed with another of the same device.There were no patient complications and the patient was fine.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a xmi thrombectomy system.The pump, effluent/supply line, shaft and tip were microscopically, tactile and visually inspected.Blood was present outside and inside of the device.There was fluid present in the boot.Inspection of the device presented no damage or other irregularities.Functional testing was performed by placing the device in the angiojet console.Functional testing showed a leak at the male connector with female luer during the prime cycle.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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 displayed during the procedure.An angiojet® ultra xmi® thrombectomy set was selected for a thrombectomy procedure.During use inside the patient, a check saline supply error message displayed.The device was removed from the patient's body and re-priming was attempted.The device would not re-prime.The procedure was completed with another of the same device.There were no patient complications and the patient was fine.

• Brand Name: ANGIOJET® ULTRA XMI® THROMBECTOMY SET
• 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: 6841308
• MDR Text Key: 84961721
• Report Number: 2134265-2017-08666
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072769
• 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,Followup
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 105041-001
• Device Catalogue Number: 105041
• Device Lot Number: 0019609580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2016
• 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