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

Model Number FG15150-0615-1S

Device Problem Difficult to Remove (1528)

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

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

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 pipeline flex (ped) device and catheter were returned.The ped device was found within the catheter.The ped device and catheter were decontaminated.The catheter useable length was measured to be within specification.The ped pushiwe was found extending from within the catheter hub.Upon visual inspection, no damages were found with the catheter hub or distal tip.The catheter body was found to be kinked.The ped device could not be pushed forward or removed from within the catheter.The catheter was unable to be flushed.The catheter was dissected to remove the ped device.The ped device was found separated into two segments while still within the catheter.The ped device segments were removed from within the catheter.The distal hypotube with the ptfe shrink tubing was found to be intact.The pushwire was found detached at the distal hypotube weld (solder joint).The proximal bumper, re-sheathing pad and re-sheathing marker were found to be missing.The dps restraints/sleeves appear to be in good condition.The tip coil outer coils were found to be intact but damaged with pad restraint found stuck to tip coil.The ped braid was found to be missing and not returned, as it was implanted in the patient.The detached pushwire was sent out for scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) elemental analysis.The elemental analysis of the pushwire end shows elevated sodium (na), chlorine (cl), iron (fe), silver (ag), tin (sn), chromium (cr), and oxygen (o) peaks were detected on the wire surface, and it is not possible to determine the failure mechanism of the subject wire.No other anomalies were observed.Based on the analysis findings, the ped pushwire was confirmed to have resistance during retraction and the catheter was confirmed to have catheter resistance.The returned ped pushwire was found stuck within the catheter.In addition, the returned pushwire and the catheter were damaged.From the damages seen on the catheter body (kinking) and ped pushwire was found detached at the distal hypotube weld (solder joint); it appears there was high force used.The investigation determined that these events were similar to events that had already been investigated, and another investigation is not necessary.Regarding the solder joint separation issue, in addition to excessive force, separation can occur due to inadequate solder/tinning.As the analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).Linked with mdrs: 2029214-2020-00201 2029214-2020-00202 2029214-2020-00203 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: 9804183
• MDR Text Key: 207392019
• Report Number: 2029214-2020-00202
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536041868
• UDI-Public: 00847536041868
• 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: 06/30/2022
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: JL19-032
• 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: 05/20/2020
• Supplement Dates FDA Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1