MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MICROMEWI; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 41067-01

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

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

Event Date 05/18/2021

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 part of a micromewi infusion catheter broke.The patient was undergoing treatment for lysis.It was reported that that the infusion catheter was placed on (b)(6) 2021.It was removed the next day, and as they were doing a lysis check it was noticed that part of the catheter was still in the patient.A snare was used to retrieve the catheter.A wire was placed down to the distal pt and another micromewi was placed to continue with the lysis procedure. the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).

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.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

Additional information received reported that the distal end of the catheter including both radiopaque markers broke off.This occurred when they were doing a lysis check and removed the catheter.There were no issues that resulted in the damage, and the cause of the event was unknown.

• Brand Name: MICROMEWI
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11917031
• MDR Text Key: 254023380
• Report Number: 2029214-2021-00643
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00847536008076
• UDI-Public: 00847536008076
• Combination Product (y/n): N
• PMA/PMN Number: K940634
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2021
• Device Model Number: 41067-01
• Device Catalogue Number: 41067-01
• Device Lot Number: A732844
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1