MAUDE Adverse Event Report: PHILIPS VOLCANO 1.8 MM PHOENIX ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	P18130K
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient id are unsuccessful.Facility declined to provide the information.Attempts to obtain the patient information were made via email.All reasonably known patient information is included in this report.Additional information obtained indicated manufacture¿s catheter device performed as intended.Target lesion was anterior tibial (at).The physician observed the manufacture¿s catheter was sticking when backing the device off another manufacture¿s support wire.Physician utilized fluoroscopy to see what was occurring at the device tip and found the tip of the support wire had detached from its shaft.The wire shaft (distal portion) appeared twisted and tangled.The physician attempted to keep the catheter being used on to removed device over wire; however, wire twisted on itself and made this impossible, causing physician to have to remove wire and device together the tip of the wire remains in the at vessel.Procedure was completed using a new wire from another manufacturer.Angioplasty was performed.Patient was discharged as expected.Condition ¿normal.¿ outcome of the procedure was noted as good results to vessel; however, tip of the wire remains in the patient.The implant or explant dates are not applicable to this device.Concomitant medical products: no information available.Both the manufacture¿s catheter and the guidewire were returned.The guidewire was returned to its manufacturer.Visual and microscopic inspection, and functional testing were performed on the returned device.Both the manufacture¿s catheter and handle were undamaged.No failure was detected.The probable cause for the guidewire damage is due to excessive rotations in the same direction.This was most likely caused when proper guidewire management is not performed.To prevent guidewire rotation during atherectomy, the user must lock the wire using the provided wire clip with torquer this prevents wire rotation whenever the catheter is activated.The guidewire clearly shows evidence of excessive rotation.The ifu states: ¿precaution: verify that the proximal end of the guidewire is secured within the torquer when the handle is on.Failure to do so may result in guidewire rotation and/or loss of position within the vessel.¿ the manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
During a planned therapeutic peripheral procedure, the manufacture¿s catheter device became difficult to remove over the support guidewire.[physician] stepped on fluoro, tip of wire was detached from shaft of wire.The distal shaft of wire was twisted on itself.A portion of another manufacture¿s guidewire remains in the patient.This adverse event (ae) is being submitted because the manufacture¿s device is a concomitant device in use when the ae of tip separation from another manufacture¿s device occurred.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.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.(b)(6).
Event or Problem Description
This follow-up supplemental report #1 is being submitted to correct inadvertent omissions and corrections in the initial report submission.

• Brand Name: 1.8 MM PHOENIX ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 8725529
• Report Number: 2939520-2019-00042
• Device Sequence Number: 1859835
• Product Code: MCW
• UDI-Device Identifier: 00845225002619
• UDI-Public: (01)00845225002619(17)201031(10)10081809
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K140944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019
• Report Date (Section F): 01/01/2005

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: 10/31/2020
• Device Model Number: P18130K
• Device Catalogue Number: 400-0200.290
• Device Lot Number: 10081809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 06/22/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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: INTRODUCER SHEATH.014 SUPPORT WIRE.014 WIRE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 68
• Date Report Sent to FDA: 01/01/2005