MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA; CATHETER, CONTINUOUS FLUSH

Model Number	FG15150-0630-1S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The phenom catheter has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed and an event cause could not be conclusively determined from the provide information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of phenom separation.The patient was undergoing embolization treatment for a medium unruptured amorphous internal carotid artery aneurysm, measuring 15mm, landing zone distal 4.2mm, proximal 4.25mm.The vessel was observed severely tortuous.The devices were prepared as indicated in the ifu.A continuous heparinized saline flush was maintained during the procedure.It was reported that during the procedure, a flow diversion device was advanced into phenom catheter.Phenom catheter broke distally.The flow diversion device and phenom were then removed as a unit from the patient.There had reportedly been no friction/difficulty during delivery.Force had been applied.There was not any patient symptoms or complications associated with this event.
Additional Manufacturer Narrative
The pipeline flex embolization device (model: ped-450-16 lot: a324633) and phenom 27 catheter (model: fg15150-0630-1s lot: oc18-062) were returned for analysis within a shipping box; within a secondary shipping box; within an opened pipeline flex outer carton and within an opened pipeline flex inner pouch.The pipeline flex embolization device was returned within the phenom 27 catheter.The pipeline flex embolization device was returned with an introducer needle on the proximal end of the pushwire.The pipeline flex pushwire (with introducer needle) was found bent at ~22.0cm and ~24.5cm from the proximal end.In addition, the pipeline flex pushwire was found bent from ~26.5cm to ~34.5cm from the proximal end.The phenom 27 catheter was returned with an rhv attached to the hub.The phenom 27 catheter total length was measured to be ~160.5cm (reference 156.5cm) and the useable length was measured to be ~154.0cm which is within specification (specification 150cm ± 5cm).No bends or kinks were found with the phenom 27 catheter body.The inner braid wire was found protruding out from the phenom 27 catheter body at ~31.0cm from the distal tip.No breaks or separations were found with the phenom 27 catheter body.The pipeline flex ptfe sleeves and tip coil were found protruding out from within the phenom 27 distal tip.The pipeline flex tip coil was found bent.For further examination, the pipeline flex embolization device was pulled out from within the phenom 27 catheter lumen with difficulty.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The proximal bumper, re-sheathing pad, distal marker and ptfe sleeves were found to be in good condition.The braid was not returned.The reason for the brain not returning was not provided.The phenom 27 catheter was flushed, water exited from the distal tip.The phenom catheter was then tested by running an in-house mandrel into the hub and through the distal tip.The in-house mandrel passed through the phenom 27 catheter hub and tip without issue.No other anomalies were observed.Based on the device analysis and reported information the customer¿s report of ¿resistance during retrieval¿ and ¿lockup/resistance at distal segment of catheter¿ were confirmed.From the damages seen on the devices; it appears there was high force used (pushing and pulling).It is likely these damages occurred when the customer attempted to retrieve the pipeline flex through the phenom 27 catheter against resistance.It is possible that the patients ¿severely¿ tortuous anatomy may have contributed to the reported issues.Regarding the customer¿s report of ¿catheter separation/break¿ the issue could not be confirmed.No breaks or separations were found with the catheter body.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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: CATHERA
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8445935
• Report Number: 2029214-2019-00227
• Device Sequence Number: 16229487
• Product Code: KRA
• UDI-Device Identifier: 00814584029001
• UDI-Public: 00814584029001
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: FG15150-0630-1S
• Device Catalogue Number: FG15150-0630-1S
• Device Lot Number: OC18-062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1