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

Model Number 107171-002

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that an error message displayed during aspiration.An angiojet ultra pe catheter was selected for a thrombectomy procedure in the pulmonary artery.The device was introduced over the guidewire and activated.After 3-5 seconds of aspiration, an error message displayed to ¿control the saline supply¿ with instructions to reset the alarm and the device stopped working.It was observed that the luer was leaking which disallowed the system to work.The procedure was completed with another pe catheter successfully.There were no patient complications and the patient was stable.

• Brand Name: ANGIOJET® ULTRA PE
• 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: 6565035
• MDR Text Key: 75094497
• Report Number: 2134265-2017-04924
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 107171-002
• Device Lot Number: 19147583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• 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: 59 YR