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

Model Number FG15160-0615-1S

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/09/2023

Event Type  Injury  

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.

Event Description

Medtronic received information that a phenom catheter tip came off.During a stroke with an m1 clot the catheter tip came off and went intercranial.The tip was entrapped/stuck.It broke in the distal location.The access vessel was the femoral.A stent retriever or aspiration catheter was not used during the procedure at that point.Just the wire.The tip was retrieved with penumbra aspiration.The patient was undergoing mechanical thrombectomy for stroke.There was no significant vessel tortuosity.No patient symptoms or complications were reported.

Event Description

Additional information received reported that no complications were associated with the indicated complaint.The physician reported that it was possible that the microcatheter had bent or kinked during the advancement up the cello bgc since the size of the bgc is so much larger than the microcatheter and they do sometimes see bending into a j type shape during advancement within the cello.There was no significant pressure, tortuosity, or substantial twisting noted beyond what they normally expect.The physician put the microcatheter in the ica.The evt was targeting a clot at the ica terminus (a t clot).They pulled the wire out of images and when they put the wire back into the microcatheter they noticed that the wire did not cross/ go through the microcatheter tip marker.This told them something was wrong and they pulled out the microcatheter and wire and identified the tip was missing.At this point they advanced a penumbra aspiration catheter and the pressure of moving this catheter up did cause the microcatheter tip that was still loose in the vessel to migrate distal.The t clot did not allow the micro tip to migrate to far.The penumbra aspiration catheter was able to draw the microcatheter tip out of the vessel.

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#: (b)(4): as found condition: the phenom 27 catheter was returned for analysis within the inner pouch; 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 ~1.0cm to 15.2cm 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 0.0260¿ 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.However, the cause could not be determined.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.

• 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: 16550874
• MDR Text Key: 311371752
• Report Number: 2029214-2023-00481
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K180959
• 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,Followup,Followup
• Report Date: 05/22/2023

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: FG15160-0615-1S
• Device Catalogue Number: FG15160-0615-1S
• Device Lot Number: 224699887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 03/29/2023; 05/19/2023
• Supplement Dates FDA Received: 04/03/2023; 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention