MAUDE Adverse Event Report: COVIDIEN (IRVINE) CATHETER FG15150-0615-1S; CATHETER, CONTINUOUS FLUSH

Model Number	FG15150-0615-1S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation; product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that during a stroke case, the phenom microcatheter's distal marker separated in the anatomy during procedure.It was reported that medtronic balloon guidecatheter and the phenom advanced into the right middle cerebral artery (mca).The phenom was unable to be advance pass the mca, therefore, the devices were retrieved.Resistance was felt and a follow up angio was taken.It was noted that the phenom distal marker was in the right mca/ m1.Upon completing the intervention, the marker was noted to have traveled to the temporal m1 area.The anatomy was reported to have severe tortuosity.The patient did not have a neurological decline associated with the detached marker.There is not any plan to remove the detached phenom.027 marker from the patient.
Additional Manufacturer Narrative
Device evaluation the phenom micro catheter was returned for analysis.The phenom micro catheter body was found to be kinked and flattened.The phenom micro catheter distal tip was found to be attached; however, the marker band was found to be missing.The marker band was not returned.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿marker band dislodge¿ was confirmed as a portion of the distal tip and marker band were found missing.However, the cause for the separation could not be determined.The lot history record review of the reported lot number showed no discrepancies that would have contributed to the reported experience.In addition, all products are 100% inspected for damages and irregularities during manufacture.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CATHETER FG15150-0615-1S
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA
• MDR Report Key: 8074145
• Report Number: 2029214-2018-00941
• Device Sequence Number: 19311154
• Product Code: KRA
• UDI-Device Identifier: 00814584028981
• UDI-Public: 00814584028981
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K151638
• 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,Followup
• Report Date (Section B): 02/20/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: FG15150-0615-1S
• Device Lot Number: JA18-011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 01/26/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 02/20/2019
• 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: Other
• Patient Age: 64 YR