MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; CATHETER, CONTINUOUS FLUSH

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

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Hematoma (1884); Nausea (1970); Vomiting (2144)

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

Knippa s., vernon s.(2021) evidence-based management of a patient with an ekos catheter.Crit care nurse.41(2), pp.78-80.Date of event was approximated using year of article publication.

Event Description

It was reported via literature article that the patient was hospitalized.A patient presented to the hospital with significant left-sided abdominal pain.The patient was found to have a thrombus within the celiac artery for which they underwent a catheter-assisted thrombolysis procedure.Hypercoagulable work-up revealed evidence of a jak 2 v617f mutation, which is indicative of polycythemia vera.The patient returned the following day with considerable left-sided flank pain associated with shortness of breath, nausea, and vomiting.Ct performed showed evidence of an expanding left renal subcapsular hematoma.Patient was treated conservatively with iv fluids and pain medication before they were discharged hemodynamically stable after a few days.

Manufacturer Narrative

Corrections: e1 initial reporter first and last name; literature article citation; full literature article pdf attached.Iskander p.(2021).A case of subcapsular renal hematoma status post celiac artery thrombectomy.International journal of surgery case reports, 81, 105798.Https://doi.Org/10.1016/j.Ijscr.2021.105798.B3: date of event was approximated using date of article publication.

Event Description

It was reported via literature article that the patient was hospitalized.A patient presented to the hospital with significant left-sided abdominal pain.The patient was found to have a thrombus within the celiac artery for which they underwent a catheter-assisted thrombolysis procedure.Hypercoagulable work-up revealed evidence of a jak 2 v617f mutation, which is indicative of polycythemia vera.The patient returned the following day with considerable left-sided flank pain associated with shortness of breath, nausea, and vomiting.Ct performed showed evidence of an expanding left renal subcapsular hematoma.Patient was treated conservatively with iv fluids and pain medication before they were discharged hemodynamically stable after a few days.It was further reported that the patient presented to the hospital due to 2 days of persistent left-sided abdominal pain.The pain was associated with significant nausea and diarrhea; oral intake worsened the pain while the use of pepto-bismol gave slight relief.On ct exam of his abdomen and pelvis, he was found to have an enlarged spleen measuring 15.2 cm x 7.1 cm x 13.3 cm in sagittal, trans-verse, and anterior-posterior dimensions, as well as having a few diverticula.His pain improved with the incorporation of iv fluids and pain management; he was discharged later on that day.He presented back 12 days later complaining of similar pain, now more localized to the left upper quadrant.Repeat ct of abdomen and pelvis showed similar splenomegaly compared to previous scan.A soft tissue filling defect in the lumen of the celiac artery, suspicious of a thrombus vs soft noncalcified plaque, was also noted; it extended all the way to the common hepatic artery and splenic artery.At this time he was started on iv heparin.An ekosonic endovascular system (ekos) catheter was introduced by an experienced vascular surgeon through the left iliac artery and positioned in the proximal portion of the celiac trunk to assist in a catheter assisted thrombolysis; alteplase infusion was also initiated at 1 mg/hr as well as a heparin infusion at 500 units/hr.The patient tolerated the procedure well.The catheter was removed at bedside the following day and was discharged on aspirin and apix-aban for anticoagulation, for which he was instructed to take for at least 3 months.At this time, a hematology consult was performed due to elevated hemoglobin levels up to 18.1.An anticoagulation work-up was ordered which consisted of factor v leiden, prothrombingene mutation, lupus anticoagulant, anticardiolipin antibodies, homocysteine level and jak2 mutation.Protein c, protein s, and antithrombin iii were withheld due to the patient being on heparin at the time.Jak2 mutation and erythropoietin levels were also ordered due to suspicions of an underlying myeloproliferative disorder (ie/ polycythemia vera).Of the test ordered, a jak2 v617fmutation was found.The next morning the patient arrived back in the ed in significant amount of pain associated with shortness of breath and nausea.The pain persisted despite being given a dose of morphine and fentanyl; a dose of dilaudid later on eventually seemed to provide some relief.Ct angiogram of the chest showed no evidence of a pulmonary embolism.A ct scan of his abdomen and pelvis with and without contrast showed redemonstration of his celiac thrombus and splenomegaly.This time, however, his left kidney showed evidence of a left subcapsular hematoma (no measurements recorded on official read) with perinephric fat stranding and delayed excretion.An enhancement anterior to the left superficial femoral artery was also noted suspicious for a pseudoaneurysm.The patient noted that he took his dose of 325 mg of aspirin and 5 mg of apixaban that morning.Anticoagulation was held, urinary catheter was placed and was patient was made npo.Nephrology team was consulted and recommended for the patient to remain off anticoagulation and on bed rest.They would follow the patient with serial hemoglobin levels and ct scans.Repeat ct scan 3 days later showed an increase in hematoma size (now measuring up to 3.6 cm) and retroperitoneal fat stranding - now extending adjacent to the abdominal aorta.The previous enhanced area suspicious for pseudoaneurysm in the left groin was no longer appreciated.The patient was monitored for the next 3 days and managed conservatively with iv fluids and pain medication.They remained to be hemodynamically stable and was discharged with instructions to follow up with his urologist and vascular surgeon in a week.

• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12957961
• MDR Text Key: 281904904
• Report Number: 2134265-2021-15530
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Sex: Male