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

Model Number 114610-002

Device Problems Crack (1135); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone (b)(6).(b)(4).Device evaluated by manufacturer: the pump, hypotube, shaft, and tip were microscopically and tactile inspected.Inspection revealed that the male connector that attaches to the pump was cracked/damaged.Functional testing was done by placing the device in the console, fluid was leaking from the crack in the connector and the device would not get into priming mode.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 root cause has been determined to be related to a supplier manufacturing issue.(b)(4).

Event Description

It was reported the device broke and stopped aspiration during the procedure.During the use of an angiojet® zelantedvt¿ catheter in a pulmonary embolism procedure, the device was set up properly as usual.After running the catheter for forty seconds it stopped working.At this point, after checking over the console and catheter, it was noticed the outlet adaptor nut on the pump assembly was cracked.The device was removed from the patient and the procedure was completed with manual aspiration with no consequences to the patient.

• Brand Name: ANGIOJET® ZELANTEDVT¿
• 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: 6673942
• MDR Text Key: 78604112
• Report Number: 2134265-2017-06977
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151313
• 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: 06/06/2017

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: 12/31/2018
• Device Model Number: 114610-002
• Device Lot Number: 20232743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2017
• 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