MAUDE Adverse Event Report: CATHERA, INC. PHENOM CATHETER; CATHETER, CONTINUOUS FLUSH

Model Number FG15150-0615-1S

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that one pipeline failed to deploy and two delivery systems became stuck upon removal.The patient was undergoing surgery for treatment of a left, saccular, unruptured aneurysm with a max diameter of 5mm and a 8mm neck diameter.It was noted the patient's vessel tortuosity was severe.It was reported that the first pipeline (pli40) was delivered to the distal ica terminus.The wire was retrieved, and upon pulling out the wire, it became stuck in the middle segment of the phenom 27 microcatheter.Everything was removed, a second phenom 27 was delivered followed by a second pipeline (pli30).The pipeline became twisted and would not straighten out or open after numerous re-sheathing and re-deployment attempts.Upon removal, the pipeline became stuck about halfway, and the entire system was removed.A third phenom 27 was used and successfully delivered the second pipeline into the patient successfully to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a neuron max and navien 58.

Manufacturer Narrative

D10.Device available, return date - additional information g4.Date manufacturer received - additional information g7.Type of report - additional information h2.Follow-up type - additional information h3.Device evaluation, device returned - additional information h6.Evaluation codes - additional information, device evaluation h10.Additional manufacturer narrative - additional information, device evaluation the phenom-27 catheter and pipeline flex (ped) device were returned.The ped delivery system and phenom catheter were decontaminated.The ped delivery system was returned stuck within the phenom catheter with the pushwire extending from hub.The phenom-27 catheter useable length was measured to be within specification.Upon visual inspection, no damages were found with the phenom hub.The catheter body was found to be kinked at distal tip.The distal tip was found to be intact.The ped delivery system was unable to be removed from the phenom.The pipeline flex was then removed by dissecting the phenom-27 catheter.The phenom catheter was unable to be flushed or tested with an in-house mandrel due to having to be dissection.The pushwire was found to be bent.The ptfe was found to be wrinkled.The distal hypotube was found to be stretched and the ptfe pulled back.The proximal bumper, re-sheathing marker and re- sheathing pad were found to be intact.The dps sleeves were found to be intact.The tip coil was found to be damaged but intact.The ped braid was found to be collapsed and frayed on proximal end and frayed on distal end.Based on the analysis findings, the ped pushwire was confirmed to have resistance during retraction and the phenom catheter was confirmed to have catheter resistance.The returned pipeline flex pusher was found stuck within the phenom catheter and the devices were found damaged.From the damages found on the devices, it appears there was high force used.It is likely these damages occurred when the attempted to advance/retrieve the ped pushwire through the catheter against resistance.It is likely that the patient¿s severe tortuous anatomy may have contributed to the resistance during retraction.Linked with mdrs: 2029214-2020-00201 2029214-2020-00202 2029214-2020-00203 2029214-2020-00483 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: PHENOM CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): CATHERA, INC.; 627 national ave.; mountain view CA 94043
• MDR Report Key: 9804179
• MDR Text Key: 205534460
• Report Number: 2029214-2020-00201
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00814584028981
• UDI-Public: 00814584028981
• Combination Product (y/n): N
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: AU18-064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1