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

Model Number	PD24127K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Embolism (1829); Muscle Spasm(s) (1966)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturers policy.Attempts to obtain patient information are unsuccessful.Attempts to obtain the 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.Concomitant medical products: phoenix guidewire device not returned to manufacturer for analysis.Recall & correctional/removal number: do not apply to this submission.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
There is no allegation the manufacturers device malfunctioned.It was reported during a planned therapeutic peripheral procedure, the manufacturers device successfully debulked the desired lesion.Resistance was experienced, the manufacturers atherectomy device and another manufacturers guidewire device were removed together.The manufacturers device was discarded.After removal of the devices x-ray showed the tip of the guidewire remained in the superficial femoral artery (sfa).The tip was removed with a microsnare.During tip retrieval a distal embolization occurred and was treated with an aspiration catheter and nitroglycerin.The patient was reported as "fine" at the end of the procedure.Final angiography indicated the lesion was well treated and distal blood circulation was "fine".Lesion: calcified lesion from the proximal sfa up to the p2 segment.This adverse event is being submitted because the manufactures device is a concomitant device in use when another manufactures device separated in a patient.There is no allegation the manufacturers device malfunctioned.

• 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: 11155154
• Report Number: 2939520-2021-00002
• Device Sequence Number: 14094495
• Product Code: MCW
• UDI-Device Identifier: 00845225002633
• UDI-Public: (01)00845225002633(17)220731(10)07072007
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K151145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2021

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: 07/31/2022
• Device Model Number: PD24127K
• Device Catalogue Number: 400-0200.294
• Device Lot Number: 08132001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR