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

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

Patient Problems Aneurysm (1708); Hematoma (1884); Hemorrhage/Bleeding (1888); Paralysis (1997)

Event Date 12/25/2018

Event Type  Injury  

Manufacturer Narrative

Shannon, n.B., kumar, p., tay, k.H., tan, s.Y., chng, s.P., & tay, h.T.(2020).Spontaneous spinal epidural haematoma following intra-arterial catheter-directed thrombolysis: a case report.Sage open medical case reports, vol 8: 1-5.

Event Description

It was reported via journal article that a hematoma developed causing paralysis and lower limb amputation.The patient presented with severe right lower limb pain associated with numbness, coldness, weakness, slight duskiness and mild mottling of the forefoot.The patient was diagnosed with acute-on chronic right lower limb ischemia.A diagnostic angiogram was performed under local anesthesia and revealed a distal abdominal aortic aneurysm and a left common iliac artery aneurysm.There was an acute occlusion of the right superficial femoral artery (sfa) extending into the popliteal and tibial arteries.The thrombotic occlusions within the sfa, popliteal artery and tibioperoneal trunk were treated with pulse-spray thrombolysis (180,000 units urokinase) and rheolytic mechanical thrombectomy using a 6 f solent proxi angiojet catheter.Angiogram did not demonstrate either anterior tibial artery (ata) or posterior tibial artery (pta) stumps after clearing the proximal occlusions.The distal ata was faintly visible and severely stenotic.As these indicated chronic occlusions of the ata and pta, no attempt was made to recanalize them.The distal sfa was ectatic and had some residual thrombus within it which was treated with balloon angioplasty, with angioplasty performed to the tibioperoneal trunk and peroneal artery as well.Flow to the foot was ultimately re-established.As there were still some minor residual thrombi within the ectatic segment of the distal sfa at the adductor hiatus and popliteal artery, low-dose urokinase and heparin were administered overnight (30,000 and 900 iu/h, respectively) via a non-bsc infusion catheter positioned within the segment of nonocclusive residual thrombus.Post procedure, the patient's symptoms of right lower limb pain and weakness resolved along with the duskiness, and his ipsilateral dp pulse was restored.Six hours after, patient complained of inability to move or feel legs bilaterally.Clinical examination revealed a t4 sensory level with a near-complete loss of bilateral lower limb motor function and anal tone.Pulses remained strong in both feet.Ct of the brain demonstrated a small subarachnoid hemorrhage within the posterior fossa with blood in the foramen magnum and fourth ventricle as well as superior herniation of the brain stem.Mri spine showed extensive hemorrhage within the thecal sac from the foramen magnum to t9 involving both subdural and subarachnoid compartments with compression of the cord at multiple levels.Focal epidural hematomas were present at t2 to t3 measuring 4 mm x 5 mm and posterolateral to c5 to c6 measuring 3 mm, with anterior epidural hematoma extending from t2 to t9 levels and there was edema of the cord from c2 to t8.A repeat angiogram of the right lower limb three hours after discontinuation of thrombolytic and heparin infusion showed re-occlusion of the sfa.The patient subsequently underwent an above knee amputation for his nonviable right lower limb.Intraoperatively, a 3 x 3 cm area of necrotic adductor muscle was present at the incision line requiring proximal debridement.Furthermore, a 4 cm distal sfa aneurysm was encountered, containing extremely firm established thrombus.The thrombus was removed piecemeal with considerable effort using an artery forceps to crush and avulse the thrombus and the proximal sfa trawled with a non-bsc embolectomy catheter restoring forward flow.The wound subsequently healed well.The patient has since developed a lower limb below knee deep vein thrombus with pulmonary artery embolism necessitating placement of a retrievable inferior vena cava filter and anticoagulation with enoxaparin, which was initially complicated by a large gluteus medius hematoma.The enoxaparin was subsequently resumed with close follow-up by a hematologist.Patient remains paraplegic and wheelchair bound.

• Brand Name: ANGIOJET SOLENT PROXI
• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10022112
• MDR Text Key: 189836294
• Report Number: 2134265-2020-05960
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K101406
• 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: 05/04/2020

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?: Yes
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 79 YR