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

Model Number FG13160-0615-1S

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/31/2023

Event Type  malfunction  

Event Description

Medtronic received information regarding a phenom 21 microcatheter that had difficult navigation during the procedure and the marker band or distal tip was broken.The patient was undergoing a thrombectomy procedure in an internal carotid artery (ica) m2 branch to treat acute ischemic stroke.Vessel tortuosity was severe.It was reported that the phenom 21 microcatheter and all accessory devices were prepared as indicated in the instructions for use (ifu).The catheter tip was not shaped.When trying to navigate the microcatheter through very tortuous anatomy to the m2, it could not pass the ophthalmic segment.After several failed attempts, it was decided that more support was needed.The system was changed to include a neuron max with the same catalyst 6 distal access catheter.At that time and without feeling any different, the physician realized that the phenom microcatheter no longer had the tip marker and that the marker had embolized a distal branch that would not have a major clinical impact.The phenom 21 microcatheter was removed and replaced with another phenom 21 microcatheter which was able to navigate without difficulty.No additional surgical or medicinal intervention was required.The separated marker band remains in the patient frontal m4.Despite the marker band remaining in the distal patient vessel there were no associated patient symptoms.Ancillary devices: cello 9f balloon guide catheter, synchro 14 guidewire, catalyst 6 distal access catheter, neuron max.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Manufacturer Narrative

Product analysis: ¿ as found condition: the phenom 21 catheter was returned for analysis within the outer carton; inside of a biohazard bag and a shipping box.¿ visual inspection/damage location details: upon visual inspection, no issues or irregularities were found with the catheter hub.The catheter body appeared to be flattened at ~1.8cm to 15.6cm from the catheter tip.The catheter distal tip and marker band were found to be separated and missing.The outer and inner tubing material at the broken end exhibited with jagged edges and stretching.The inner elliptical wire at the distal broken end was found to be exposed.No other anomalies were observed.¿ testing/analysis: the total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and found patent.The catheter was then tested by running an in-house 0.016" mandrel through catheter hub.The mandrel successfully passed through the catheter hub with no issues; however, resistance was observed at the damaged locations.¿ conclusion: based on the device analysis and reported information, the customer complaint was confirmed as the distal tip and marker band were separated and missing.In addition, the catheter body was flattened/stretched at several locations.The broken end exhibited jagged edges and stretching which indicate that the catheter separated when exceeding the tensile strength of the tubing material.From the damages seen on the catheter; it appears there was high force used.It is possibly these damages occurred when the customer attempted to advance the catheter against resistance.However, the cause could not be determined.Possible cause includes severe vessel tortuosity.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: 16702975
• MDR Text Key: 312912090
• Report Number: 9612164-2023-01522
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2023

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
• Device Operator: Health Professional
• Device Model Number: FG13160-0615-1S
• Device Catalogue Number: FG13160-0615-1S
• Device Lot Number: 225857233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2023
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 04/13/2023; 05/23/2023
• Supplement Dates FDA Received: 04/18/2023; 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2023
• 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
• Patient Age: 83 YR
• Patient Sex: Female