MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number UNKNOWN

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

Patient Problem Hematoma (1884)

Event Date 01/13/2017

Event Type  Injury  

Manufacturer Narrative

This patient received ekos therapy on (b)(6) 2017 and developed a retroperitoneal hematoma during treatment.The patient was enrolled in a retrospective study - (b)(6) (subject (b)(6)).The principle investigator assessed the retroperitoneal hematoma as serious and definitely related to the interventional procedure and probably related to the ekos system, thrombolytic drug and anticoagulant drug.The btg physician is in agreement with the principle investigator's assessment that the event is related to the interventional procedure.The btg physician assessed the retroperitoneal hematoma as related to the interventional procedure, thrombolytic drug and/or anticoagulant drug, and possibly related to the ekos system.This event is being reported due to the relationship assessment made by the principle investigator as definitely related to the interventional procedure and probably related to the ekos system.No device serial numbers were documented in the clinical study file.No additional information will be available.

Event Description

A (b)(6) female patient was treated with ekos on (b)(6) 2017 for a bilateral pe.Ekos treatment was terminated on (b)(6) 2017 (approximately 8 hours of "threatment").The patient "recieved" a total dose of 10 mg r-tpa (5 mg r-tpa through catheter placed in right pulmonary artery and 5 mg r-tpa through catheter placed in left pulmonary artery).The patient developed a retroperitoneal hematoma during the study treatment and developed hypotension a few hours after ekos procedure w/map 60-64 and hb dropped to 8.9 from 13.2 pre-procedure.The patient received non-surgical drug treatment (saline bolus 2000ml iv) and a transfusion of rbc (2 units/350 ml).The retroperitoneal hematoma resolved on (b)(6) 2017.This event was not reported to the manufacturer by the treating physician at the time of the event.Anticoagulation summary: on (b)(6) 2017: aspirin 324mg po, heparin bolus 5000iu iv, heparin infusion 1500units/hr iv.On (b)(6) 2017: aspirin 81mg po, heparin infusion 1200units/hr iv.On (b)(6) 2017: enoxaparin 90mg sc, heparin infusion 1300units/hr iv.On (b)(6) 2017: heparin infusion 1200units/hr iv.On (b)(6) 2017: heparin infusion 1300units/hr iv.On (b)(6) 2017: apixaban 10mg po.This patient was enrolled in a retrospective study (b)(6) (subject (b)(6)).The investigator assessed the event as serious and definitely related to the interventional procedure and probably related to the ekos system, thrombolytic drug and anticoagulant drug.

• 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: 8184645
• MDR Text Key: 131044730
• Report Number: 3001627457-2018-00040
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 11/29/2018
• 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): Hospitalization
• Patient Age: 73 YR