MAUDE Adverse Event Report: PHILIPS VOLCANO PHOENIX CATH SYSTEM, 2.4MM X 127CM, 7F (KIT); CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	PD24127
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Block a5/g3: patient ethnicity and race was inadvertently missed in the initial mdr.

• Brand Name: PHOENIX CATH SYSTEM, 2.4MM X 127CM, 7F (KIT)
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11319780
• Report Number: 2939520-2021-00007
• Device Sequence Number: 14313743
• Product Code: MCW
• UDI-Device Identifier: 00845225002633
• UDI-Public: (01)00845225002633(17)221130(10)10302004
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K151145
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: PD24127
• Device Catalogue Number: 400-0200.294
• Device Lot Number: 12102005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/20/2021; 02/03/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 05/05/2021; 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHOENIX GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR