MAUDE Adverse Event Report: VOLCANO CORPORATION EAGLE EYE PLATINUM CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 85900PJ

Device Problems Loose or Intermittent Connection (1371); Physical Resistance (2578)

Patient Problem Cardiac Arrest (1762)

Event Date 05/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to philips volcano policy.This case involves a (b)(6) year-old male patient with total occlusions of the distal aorta and both common iliac arteries (so-called leriche syndrome1).A complex endovascular procedure was performed to re-establish antegrade line flow through the external iliac arteries.The procedure involved right radial and bilateral femoral arterial access, crossing the occluded aortic stump and both occluded iliac arteries, kissing balloon angioplasty, bilateral external iliac artery stent implantation, and finally kissing balloon post-dilation of the stents.Imaging from the first catheter used in this case was lost during attempts to cross the aortic occlusion.A second catheter was used to provide ivus imaging thereafter.The difficulty that was encountered during attempted catheter crossing of the occluded, calcified, and tortuous aortic bifurcation is not unexpected.According to the case description, multiple attempts and multiple devices were required to successfully cross the lesion.A ct scan revealed a calcified occlusion that was characterized as "hard" during the case.The patient experienced a "momentary" episode of cardiac arrest (treated with atropine) during pre-stent kissing balloon angioplasty of the external iliac arteries, which was post-removal of the second catheter.Per the physician, the patient's age, naturally low blood pressure, and the combination of pain and vasovagal response was believed to be the cause of the cardiac arrest.The returned device was inspected.There was wear on the weld leg traces.Intermittent open connections were present on every circuit.The device was recognized by the imaging system and initially produced a clear image.Upon manipulation of the device at the distal shaft, the image and connection signal both became intermittent.The device was inspected and no bends or kinks were observed.The mandrel encountered no resistance during the guidewire test.The proximal and distal fillet were measured and both had diameters within product specifications.The device was run through a tortuous path and no abnormalities with handling were observed.The could not cross portion of the complaint could not be duplicated or confirmed by the investigation.The probable cause of the imaging related failure would be wear present on the weld leg traces as a likely result of bending on the weld legs during the manufacturing process.Strain, impact, and forces associated with use can affect the integrity of the electrical connections within the device.It could not be determined when the cause of the failure occurred.The instructions for use (ifu) list myocardial infarction [heart attack] as a possible adverse effect: possible adverse effects include, but are not limited to, the following: myocardial infarction; occlusion; coronary vessel dissection; perforation, rupture or injury; restenosis; hemorrhage or hematoma; unstable angina; arrhythmias; drug reactions; allergic reaction to contrast medium; hypo/hypertension; infection; vessel spasm; arteriovenous fistula; embolism; entry puncture site bleeding; vascular wall injury; vessel thrombosis; pseudoaneurysm (at site of catheter insertion); renal failure; coronary aneurysm; vessel trauma requiring surgical repair or intervention, death.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.To date, no other complaints were reported for this same failure mode within this lot.We will continue to monitor these types of complaints.

Event Description

It was reported the case involved a male, (b)(6) years old, leriche syndrome (bilateral iliac occlusion, abdominal aorta stenosis).The user was approached from right radial artery with a guiding sheath: parent plus 4.5fr/98cm and inserted an angiographic catheter: jr4 4fr/120cm under renal artery, then inserted a guiding sheath: parent plus 6fr/26cm from left femoral artery and inserted an indwelling needle: 20g surflo with y-connector from right femoral artery.From left femoral artery, the user approached to the occluded part with a micro catheter: prominent neo90cm and a guidewire: cruise 0.014"/175cm, then soon changed the guidewire to naveed hard 15 0.014"/190cm.According to the ct scan, the inside of the calcified part was possibly soft, but indeed hard.For the backup, an angiographic catheter: ver (short angle) 4fr/65cm was inserted over the bifurcation of common iliac artery and three guidewires: chevalier pl-x 0.014"/65cm, astato xs 9-40 0.014"/200cm and naveed hard were used in dependence on each characteristic to find the route and naveed hard could cross the occluded part and was delivered to aorta.The route was observed by ivus catheter: eep and confirmed it was partially outside of the calcified part, then naveed hard was left there.The user tried to get another route with a penetration catheter: crusade pad 140cm and a guidewire: chevalier pl-x 0.014"/235cm and chevalier could cross the occluded part and was delivered to aorta, but eep could not cross around the bifurcation of the route, then eep was inserted along with naveed hard and observed the route and the user confirmed the route was better than the first route.A balloon catheter: armada 14 2.5mm/40mm was used but eep could not cross.A penetration catheter: corsair pv 134cm was used and could cross the common iliac artery but could not cross the stump of the occluded part in aorta.The image of eep was lost around this timing.The user inserted armada from right radial artery and inflated to trap the chevalier inside parent plus to strengthen guidewire backup and another eep could cross the stump of the occluded part in aorta.Another armada 2.5mm/40mm was used for the entire occluded part in left and observed by eep, the therapy was effective although a small false lumen was observed (the left route was secured).Prominent and naveed hard were inserted from right femoral artery and naveed hard could be delivered to aorta in a short time.From the left route naveed hard was observed by eep, but it was unsure.From right femoral artery eep was inserted and the user confirmed the route was effective although a small false lumen was observed in external iliac artery (the right route was secured).Two balloon catheters: armada were inserted from right radial artery and kbt (kissing balloon technique) was done for left and right common iliac artery and left and right external iliac artery at the right and left same time.The stenting position was confirmed by ct and the larger two balloon catheters: fox sv 6.0mm/60mm were inserted from right radial artery and kbt (kissing balloon technique) was done for left and right common iliac artery and left and right external iliac artery at the right and left same time again.During kbt in external iliac artery, because cardiac arrest momentary occurred, atropine sulfate was injected.Two stents: absolute pro 8mm/100mm were placed from aorta to common iliac artery in left and right, two stents: absolute pro 8mm/100mm were placed in external iliac artery in left and right and two balloon catheters: fox sv 6mm/60mm were used there for kbt and post-dilatation by 6 atm.From right radial artery, an angiographic catheter: pig 4fr was inserted and confirmed right external iliac artery was slightly appeared.The right external iliac artery was observed by eep and confirmed that the false lumen in the external iliac artery was not enough dilated.Fox sv was used and the false lumen was additionally dilated and the procedure was completed.Patient was discharged same day of the procedure in stable condition.Artery tortuousness: moderate, calcification: moderate.Attempts to obtain patient id and weight have been unsuccessful.Attempts to obtain the patient information were made via email and phone.All reasonably known patient information is included in this report.

• Brand Name: EAGLE EYE PLATINUM CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre dr ste 500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone&business park; b37; alajuela, costa rica ; CS
• Manufacturer Contact: tom brennan ; 3721 valley centre dr #500; san diego, CA 92130 ; 8587641320
• MDR Report Key: 5742452
• MDR Text Key: 47958980
• Report Number: 2939520-2016-00035
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 85900PJ
• Device Catalogue Number: 400-0200.71
• Device Lot Number: 0133 50061407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2016
• 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): Life Threatening; Required Intervention
• Patient Age: 71 YR