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

Model Number FG11150-0615-2S

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2022

Event Type  malfunction  

Event Description

Medtronic received information regarding 2 phenom 17 microcatheters that had issues prior to use with the patient.It was reported that the devices were prepared and flushed per the instructions for use (ifu).The first phenom 17 catheter had significant resistance with the non-medtronic guidewire in the distal end, so the catheter was replaced.However, the it was decided no to use the second phenom 17 catheter either because it looked like there was more than 3cm between the two markers.The phenom 17 was then replaced with a competitor's product for the procedure.There was no patient involvement.Ancillary device: synchro guidewire additional information received reported that there was no kink or damage observed to the first phenom 17 microcatheter or to the guidewire.There were no problems during preparation, and it was obviously long when viewed by fluoroscopy.

Manufacturer Narrative

H3: two phenom-17 micro catheters were returned for analysis.It was not possible to determine which device belongs to which pli and the devices will be analyzed together.The synchro guidewire used in the event was not returned for analysis.(first phenom-17) no damages were found with the phenom-17 micro catheter hub.Dried saline was found within hub.The micro catheter was found kinked at ~122.9cm.The distal tip was found undamaged.The proximal marker band was found intact, and distal marker band was found missing.The inner liner was found delaminated at the distal end.The phenom-17 micro catheter total length was measured to be ~157.6cm and the usable length was measured to be ~149.7cm, which is within specification (specification: total (ref) = 156.5cm, usable: 150cm ± 5cm).As the distal marker band was found missing, the distance between the two marker bands could not be measured.The micro catheter was flushed with water; however, water did not exit the distal end as the catheter was found occluded.An in-house 0.0160¿ mandrel was inserted into the phenom-17 micro catheter hub, through the catheter body and out the distal end with resistance encountered at ~138.0cm from the proximal end.A bunched-up strip of inner liner was pushed out of the micro catheter.(second phenom-17) no damages were found with the phenom-17 micro catheter hub.The distal ~0.7cm of the micro catheter was found damaged and stretched.The proximal marker band was found intact, and the distal marker band was found missing.The phenom-17 micro catheter total length was measured to be ~157.6cm and the usable length was measured to be ~149.2cm, which is within specification (specification: total (ref) = 156.5cm, usable: 150cm ± 5cm).As the distal marker band was found missing, the distance between the two marker bands could not be measured.The micro catheter was flushed with water; and water exit the distal.An in-house 0.0160¿ mandrel was inserted into the phenom-17 micro catheter hub, through the catheter body and out the distal end with no resistance encountered.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was confirmed for the first phenom-17 but not the second phenom-17.The cause of the resistance was found to be the damaged inner liner occluding the micro catheter.Possible causes for catheter liner damage are high force deliver, devices not hydrated prior to use with the guidewire, guidewire advanced/retracted aggressively, guidewire advanced against high resistance, or more than one device used simultaneously in the micro catheter.As the synchro guidewire used in the event was not returned for analysis, any contribution of the guidewire towards the failure could not be assessed.The synchro guidewire has an outer diameter of 0.010¿ or 0.014¿ per stryker website, which is compatible for use with the phenom-17 micro catheters.Customer reported devices were prepared and flush per ifu.The customer report of ¿marker band damage¿ was confirmed for both devices, however, the cause could not be determined as the damage was reported to have occurred prior to use.The customer report that the distance between the marker band was out of specification.This could not be confirmed as the distal marker bands for both devices were found missing.The distal micro catheter was found stretched for the second phenom-17 and the likely cause of the marker band distance issue.The cause of the catheter stretching could not be determined.It is possible the customer advanced the intraluminal device against resistance, causing the stretching.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
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15928377
• MDR Text Key: 307923372
• Report Number: 2029214-2022-02067
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG11150-0615-2S
• Device Catalogue Number: FG11150-0615-2S
• Device Lot Number: 223165486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1