PHILIPS VOLCANO PHOENIX CATH SYSTEM, 2.4MM X 127CM, 7F (KIT); CATHETER, PERIPHERAL, ATHERECTOMY
|
Back to Search Results |
|
Model Number PD24127 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Vascular Dissection (3160)
|
Event Date 02/03/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information are unsuccessful.Attempts to obtain patient information were made via email.All reasonably known patient information is included in this report.Device is not serialized.The implant or explant dates are not applicable to this device.Device not returned to manufacturer for analysis.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
|
|
Event Description
|
This case was reviewed and investigated according to the manufacturer¿s policy.It was reported during a therapeutic peripheral procedure, the physician was performing an atherectomy of two lesions in the right sfa and popliteal.During the second passage of the distal lesion the handle stopped twice.The physician reconnected the handle and we could proceed the 2nd passage of the distal popliteal lesion.The control angiography showed than a dissection in the popliteal segment and a leak of contrast media.The physician decided to make a prolonged dilatation with another manufacturers balloon device over 10 minutes with outside pressure from a blood pressure cuff.Control showed a good result with no leaks of contrast media.The physician treated the proximal lesion with an another manufacturers angioplasty balloon.The physician checked the leg from proximal up to the foot.In consultation with the vascular surgeon the decision was to keep it without stenting.Patient was fine all the time, no pain, no issues.This adverse event is being submitted because the manufactures device was used in a procedure where the patient experienced a vessel dissection.
|
|
Manufacturer Narrative
|
Blocks d10 & g4: the phoenix atherectomy system was returned for evaluation on (b)(6) 2021.Block h3: visual inspection revealed no exterior damage on the returned catheter.The torqueshaft was collapsed/damaged preventing insertion of a guidewire.Destructive analysis revealed a damaged torqueshaft consistent with the catheter being run without guidewire support.If the catheter is operated unsupported by a guidewire, there is a high probability of damaging the catheter in the manner and location exhibited by the returned device.Block h6: the ifu warns to not turn on the phoenix atherectomy system unless the phoenix atherectomy catheter is tracked over a guidewire and the distal tip of the guidewire is placed in an appropriate section of the vessel.
|
|
Manufacturer Narrative
|
Block a5/g3: patient ethnicity and race was inadvertently missed in the initial mdr.
|
|
Search Alerts/Recalls
|
|
|