MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER; CATHETER, CONTINUOUS FLUSH

Catalog Number 500-56130

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

Ekosonic mach4 30cm/135cm catheter, catalog number 500-56130, serial no.(b)(4), was returned for evaluation.The data event log from the pt3b control units involved in the case were downloaded and reviewed.The device in question delivered ultrasound assisted therapy for 19 hours.Based on the report, the device malfunction occurred at the end of therapy during retrieval of the catheter.The returned device was evaluated under microscope and using ring gauge.The fractured microsonic device (msd) exhibited plastic deformation in the treatment zone, confirming the complainant's report.During follow up, the complainants reported that they did not encounter any difficulty in placing the device over the tight bifurcation and arch, however, it was mentioned that the damage to the device could have occurred during the insertion procedure.The ifu warns users against continuing the procedure with the msd if it is damaged.Specifically, it states: "if an iddc or msd becomes kinked or otherwise damaged during use, discontinue use and replace." manufacturing records were reviewed and all applicable procedures were followed and appropriate quality inspections were performed prior to release of the catheter.A definitive root cause could not be identified, but this appears to be a use-related event.During patient outcome follow up, an ekos representative was informed that the 'patient did well, no adverse or harm from the device' (verbatim).As stated earlier, the event log shows 19 hours of ultrasound assisted run time.The complainant reported that the bypass graft he lysed treated by the device 'looked great' upon follow-up.

Event Description

During an ekosonic procedure treating a lower extremity (le) bypass graft, the control unit (cu) alarmed due to a 'device temperature too high alarm' after nineteen (19) hours of therapy.The reporter indicated that he had increased the coolant level from 35 ml/hr to 120 ml/ hr (in 10ml increments) without resolution of the alarm.The control unit (cu) was changed for a second unit and the coolant decreased to 35 ml/hr, however the alarm re occurred requiring the coolant to be increased back up to 120ml/hr.The alarm condition could not be resolved.Therefore, the physician was notified that the ultrasound was no longer functioning, and the control unit was switched off.Infusion of lytic continued as prescribed.In follow up information received by the company on 19 august 2016, the reporter stated that during the removal procedure of the msd it was noted that the wire was 'fractured to the point that it bent in two' (verbatim).The fracture was noted to have occurred within the treatment zone of the msd.The reporter indicated that the msd may have been inadvertently damaged during placement.The reporter stated that the patient 'did well, no adverse events or harm from the device, and the bypass graft he lysed looked 'great' upon follow up' (verbatim).

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer Contact: benjamin hornsey ; 11911 north creek parkway s; bothell, WA 98011-8809 ; 4254153143
• MDR Report Key: 5951507
• MDR Text Key: 54765825
• Report Number: 3001627457-2016-00019
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 500-56130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2016
• 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