MAUDE Adverse Event Report: EKOSONIC ENDOVASCULAR CATHETER EKOSONIC ENDOVASCULAR CATHETER

Model Number UNKNOWN

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

Patient Problem Anemia (1706)

Event Date 06/09/2016

Event Type  Injury  

Manufacturer Narrative

A moderate hematoma in the right groin and drop in hemoglobin and hematocrit resulted in anemia, which is a sequela of the hematoma.The patient was treated with hospitalization, laboratory tests and two units of whole blood transfusion.A ct of the abdomen and pelvis showed no evidence of a retroperitoneal bleed.Hematoma resulting in anemia are potential complication listed in the ifu and can occur after sheath removal.This clinical study sae is considered to be procedure-related and not related to the ekos device.No additional information will be available.

Event Description

Subject (b)(6) is a retrospective patient enrolled in (b)(6).This patient is a (b)(6) year old female.The patient had an abnormal ecg reading at baseline and history of tachycardia, transient hypo-hypertension (treated by medications) and diabetes.The patient's pre-procedural laboratory test results included 11.8 g/dl hemoglobin, 36.9%hematcrit and 122 k/¿ platlette count.The patient was treated for a bilateral pe on (b)(6) 2016 through (b)(6) 2016 for 24 hours.Ekos catheter was successfully placed using ultrasound imaging in the left and right pulmonary arteries.12 mg of tpa infusion was started on the same day at 22.14 hours.The planned therapy was completed at 22:14 on (b)(6) 2016.A moderate hematoma in the right groin and drop in hemoglobin and hematocrit resulted in anemia.Sae (anemia) start date (b)(6) 2016 and resolved on (b)(6) 2016.The patient was treated with hospitalization, laboratory tests and 2 units of whole blood transfusion.A ct of the abdomen and pelvis showed no evidence of a retroperitoneal bleed.Upper gi endoscopy showed la grade b reflux esophagitis.Recommendation to continue protonix and resume anticoagulation.The principle investigator classified the relationship of the anemia as not related to the ekos device and ultrasound therapy, but related to thrombolytic drug and anticoagulant drug.The interventional procedure was classified as unknown.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOSONIC ENDOVASCULAR CATHETER; 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: sandara bausback-aballo ; 300 conshohocken state rd,; 300 four falls corporate ctr.; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 8438457
• MDR Text Key: 139545703
• Report Number: 3001627457-2019-00009
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182324
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2019
• 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): Other
• Patient Age: 78 YR