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

Model Number 114610-001

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of an angiojet zelante dvt thrombectomy catheter with no other devices.The pump, shaft, and tip were microscopically examined and a break was observed in the hypotube 10 ½ cm from the tip of the catheter.Functional testing was done by placing the device in the console and during prime the console gave a ¿check saline¿ error.Fluid was leaking from the broken hypotube.The device would not function due to the hypotube break.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 is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on analysis completed on 13-feb-2017 it was reported that the catheter had resistance within the sheath.An angiojet® zelantedvt¿ catheter was selected for a deep vein thrombosis (dvt) procedure in the left common iliac and external iliac vein.After delivery tpa with the zelante in powerpulse mode, the catheter was removed through the non-bsc 8f short sheath with some resistance.The devices were removed together and a new zelante catheter was used to complete the procedure successfully.There were no patient complications.However, returned device analysis found a broken hypotube.

• 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: 6385005
• MDR Text Key: 69276895
• Report Number: 2134265-2017-01801
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151313
• 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
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 114610-001
• Device Lot Number: 20111013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2016
• 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
• Patient Age: 81 YR