MAUDE Adverse Event Report: VOLCANO ATHEROMED, INC 2.2MM X 149 CM PHOENIX ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	P22149K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism (1829)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).All reasonably known patient information is included in this report.The embolization was observed after successfully completing the atherectomy procedure.It is not known if the embolization was related to the manufacturer's device.The patient was subsequently treated with aspiration catheter and hospitalized as per plan.The patient is reported to be "mobile and can walk very well".No tests/laboratory data was available.There is no serial number associated with this product; it is referenced by lot number.The implant or explant dates are not applicable to this device.A visual examination of the catheter and handle was conducted, no damage or malfunction was observed.As such, a probable cause could not be determined.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.It was reported that after using the manufacturer's device to successfully treat an in stent "restonosis" (isr) of 7/80 in the superficial femoral artery (sfa), angiography displayed a delay in contrast media that stopped below the stent.Changing to an aspiration catheter it was observed that fresh thrombus material flushed into an external filter.After ballooning the isr with a drug coated balloon (dcb) the vessel showed a smaller diameter below the stent which was treated with a spasmolyticum and a plain old balloon angioplasty (poba).This event is being reported because the patient experienced an embolism.It could not conclusively be determined if the manufacturer's device caused or contributed to the event.

• Brand Name: 2.2MM X 149 CM PHOENIX ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): VOLCANO ATHEROMED, INC; 1530 o'brien drive, suite a; menlo park CA 94025
• MDR Report Key: 8081503
• Report Number: 2939520-2018-00181
• Device Sequence Number: 19413725
• Product Code: MCW
• UDI-Device Identifier: 00845225002633
• UDI-Public: (01)00845225002633(17)200430(10)04161806
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143328
• 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): 10/23/2018

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: 04/30/2020
• Device Model Number: P22149K
• Device Catalogue Number: 400-0200.293
• Device Lot Number: 04161806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/16/2018
• 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: 62 YR