MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemoptysis (1887); Perforation of Vessels (2135)

Event Date 12/27/2017

Event Type  Death  

Manufacturer Narrative

It was reported by the corresponding author that the complication (pulmonary artery perforation resulting in fatal hemoptysis) was thought to be related to the chronically elevated hemidiaphragm.It could not be determined if the pa was perforated by the guidewire or the ekos catheter.No device malfunction was reported.Vessel perforation and hemorrhage are known potential complications listed in the labeling.(b)(4).

Event Description

The following case report literature was reviewed on 02 nov 2018: title: pulmonary artery rupture after ultrasound-assisted catheter-directed thrombolysis.Authors: gustavo fernandez romero, bashir riyaz, rohit gupta, brian o'murchu, vladimir lakhter, claudia nieves prado, talal akhter, gary cohen, parth rali.Facility: temple university hospital, 3401 n broad st philadelphia pa 19140.Corresponding author: gustavo fernandez romero, md.Events reported: vessel perforation resulting in fatal hemoptysis.A (b)(6) female with a history of recurrent pulmonary emboli (pe), recent retroperitoneal hematoma (due to anticoagulation) and chronically elevated right hemidiaphragm found on prior imaging, presented with profound hypoxic respiratory failure due to acute pe.Patient was noted to have borderline hypotension and severe right ventricular strain.A multidisciplinary decision was made by pe response team (pert) to pursue ultrasound-assisted catheter-directed thrombolysis (uscdt) with ekos.Three hours after catheter placement, massive hemoptysis occurred requiring intubation.Bedside bronchoscopy revealed bleeding from right lower lobe (rll).A bronchial blocker was placed on the right side and the patient was taken to the catheterization laboratory for an emergent pulmonary angiogram.The source of bleeding was anterior basal segment of the rll pulmonary artery (pa).The bleeding was stopped by deploying an amplatzer vascular plug (avp) with resolution of hemoptysis.Unfortunately, the patient deteriorated and died.The reported incidence of pa rupture associated with the use of a swan ganz catheter is 0.03-0.2%; however, it is a serious complication associated with high mortality.Following a request for additional information, the corresponding author reported that the case was performed on (b)(6) 2017.The event was not reported to the manufacturer at the time of the event since the complication was thought to be related to the chronically elevated hemidiaphragm.It could not be determined if the pa was perforated by the guidewire or by the ekos catheter.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: CATHETER
• 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: sandra bausback ; 300 four falls corp. center; 300 conshohocken st rd, # 300; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 8077812
• MDR Text Key: 127372200
• Report Number: 3001627457-2018-00033
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death
• Patient Age: 75 YR