MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER; CATHETER, CONTINIOUS FLUSH, PRODUCT CODE: KRA

Catalog Number	500-55150
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Both catheters used in this case were returned to ekos.The first catheter placed was noted to have a kink on the iddc 78.5cm from the distal end of the strain relief and pinch marks along the shaft between 20cm-58cm from the distal end of the luer barb.The msd was only able to be loaded 40cm with difficulty.The second catheter was returned in three pieces, with fractures in the msd at 71.7cm and 75cm from the distal end of the strain relief.This was noted to have occurred after several attempts to place the catheter.There was also kinks noted at 24cm and 19cm from the distal end of the strain relief on the iddc as well as pinched/flattened tubing between 48cm-50cm from the distal end of the strain relief.A puncture was noted at 3cm from the distal end of the strain relief, which confirmed the reported leak of the second catheter.The ekos ifu states: "if an infusion catheter or ultrasonic core becomes kinked or otherwise damaged during use, discontinue use and replace." detailed investigated showed that the fracture regions of the treatment zone epoxy was firm and rigid and the fractures planes of the epoxy were smooth, indicating that the epoxy was cured.Manufacturing records were reviewed and all applicable procedures were followed and appropriate quality inspections were performed prior to the release of the catheter.It was noted by the ekos rep that this was an "uncommon case" anatomy-wise.The fractured msd from the second ekosonic kit used was able to be removed from the patient as enough wire was sticking out of the hub that the physician was able to remove it using a hemostat.It was confirmed under fluoroscopy that there was nothing left in the catheter.At this time, the iddc was used as a standard infusion catheter.Four hours into treatment with the second iddc, the patient noted that he felt a wet area.The ekos catheter was then removed and a standard infusion catheter was placed.The patient had swelling in the leg post 4 hours of treatment via a standard infusion catheter.The patient had the thrombus surgically removed and a new graft placed.The difficultly advancing the msd and the subsequent fracture were not suspected to contribute to the need for surgery.In a post-surgery angiogram, there was good flow reported in the affected area.
Event or Problem Description
On (b)(6) 2017 during a peripheral arteial occlusion procedure using a contralateral approach over the iliac bifurcation up and over to treat the proximal common femoral graft to popliteal, the physician reported that he experienced problems advancing the msd.The iddc was placed with no issues, however the physician noted resistance while trying to advance the msd.It was noted by the ekos rep that this case had tortuous anatomy and was an "uncommon case".The physician then tried to place another ekos catheter of the same size.The iddc of the second catheter also placed easily but the msd became difficult to track beyond the bifurcation.Additional follow-up from the ekos field representatives on (b)(6) 2017 indicated that upon attempting to advance the second msd several times, the physician was unable to do so.The last time he attempted to push the wire in, it fractured.Enough wire was sticking out of the iddc hub that the physician was able to remove it using a hemostat.It was confirmed under fluoroscopy that there was nothing left in the catheter.The physician then placed a flow switch at the msd connection and used the ekos iddc as an infusion catheter only.Four hours later, the patient stated that they felt a wet area.The catheter was noted to be leaking after four hours so the patient was brought back down to the ir for a standard catheter exchange.The patient had swelling in the leg post 4 hours of treatment via a standard infusion catheter.The patient had the thrombus surgically removed and a new graft placed.In a post-surgery angiogram, there was good flow reported in the affected area.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Common Device Name: CATHETER, CONTINIOUS FLUSH, PRODUCT CODE: KRA
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• MDR Report Key: 6483681
• Report Number: 3001627457-2017-00005
• Device Sequence Number: 850565
• Product Code: KRA
• UDI-Device Identifier: 00858593006189
• UDI-Public: 00858593006189
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2017

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
• Operator of Device: Physician
• Device Expiration Date: 09/06/2019
• Device Catalogue Number: 500-55150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 04/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1