MAUDE Adverse Event Report: EKOS CORP. EKOSONCI ENDOVASCULAR SYSTEM

Model Number 106/12CM

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Inspection of the returned device confirmed: proximal marker band dislodged from original position (witness marks in correct (12cm) location) 12 cm treatment length device.Distal edge of proximal marker band rolled over toward shaft (inside) and proximal band pushed against distal marker's proximal edge.Hole.In drug lumen distal of the original location of proximal marker ban d.King in shaft at 92cm from distal end of strain relief.Surface disruptions (waves in drug lumen) from 88cm from strain relief to distal end (indication of friction).Introducer kinked and bent to approximately 75 degrees (applies pinch/friction to iddc shaft).Connector cut from iddc, not included with catheter.135 cm device.Blood in catheter drug lumen, coolant lumen.A similar product (12cm tz, same working length) was obtained from the manufacturing line and passed through the introducer sheath returned by the complainant.Initial pass through, when the king relieved, did not dislodge the marker band.During the second attempt, through the introducer with kinked sheath, serrations (surface imperfection) similar to the complaint device were observed.In addition, strong sticktion/resistance was felt during catheter removal.Based on this failure mode duplication effort and kinked (returned unit) interface, the root-cause appears to be related.

Event Description

The interventional radiologist placed a 12cm ekos catheter to treat the right iliac artery (access was from the left).The case went well and the patient returned for a lysis check the next day.A different interventional radiologist did the check and when removing the catheter, he felt resistance so he did some imaging and noticed the marker on the ekos catheter had moved proximal to distal.He removed the sheath, and catheter together and maintained wire access.He replaced with a sheath and all components of the ekos catheter were safely removed with no adverse event or harm to the patient.No adjunctive therapy was needed and case was complete.

• Brand Name: EKOSONCI ENDOVASCULAR SYSTEM
• Manufacturer (Section D): EKOS CORP.; 11911 n creek parkway south; bothell WA 98011 8809
• Manufacturer Contact: susan wray ; 11911 n creek parkway s.; bothell, WA 98011 ; 4254891267
• MDR Report Key: 5207243
• MDR Text Key: 30700677
• Report Number: 3001627457-2015-00007
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 106/12CM
• Device Catalogue Number: 500-56112
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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