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

Model Number 41064-01

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

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

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not received.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that micrormewi got caught inside of cragg mcnamara and tip dislodged inside of the catheter.It was reported that the physician put the micromewi through a cragg mcnamara.The staff was notified that this usage is off label and probably contributed to the micromewi getting stuck inside.The target location was left middle superficial femoral artery.There were no patient symptoms or complications associated with this event.Instruction for use (ifu) was not followed during preparation, procedure, post-procedure.

Manufacturer Narrative

The device has been received and is currently under analysis.A supplemental report will be submitted when the investigation has been completed.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

The cragg mcnamara catheter was returned for analysis.It was reported that the micromewi catheter tip was returned within the cragg mcnamara.The remaining portion of the micromewi catheter was discarded at the site.The cragg mcnamara catheter was decontaminated.The cragg mcnamara total length was measured to be within specification.No damages or irregularities were found with the cragg mcnamara hub.No bends or kinks were found with the cragg mcnamara catheter body.The cragg mcnamara proximal and distal markers were found intact.The cragg mcnamara catheter was flushed, water exited from the infusion holes.An in-house 0.035¿ guidewire was inserted into the cragg mcnamara catheter lumen; however, became stuck within the distal tip.The cragg mcnamara catheter body was dissected (cut) at the distal tip.The micromewi catheter tip was found within the cragg mcnamara catheter lumen.The micromewi catheter tip was removed from within the cragg mcnamara catheter lumen without issue.The micromewi catheter length was measured to be ~26.2cm (10.3¿).When compared to the product drawing ~49.5cm (19.5¿) of the micromewi catheter usable length was found missing and was not returned.In addition, when compared to the product drawing the micromewi catheter appears to have separated at a fuse joint.The tubing material of the micromewi separated end exhibited stretching, necking and jagged edges.No bends or kinks were found with the micromewi catheter segment.The micromewi proximal and distal markers were found intact.No other anomalies were observed.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: 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: 8424918
• MDR Text Key: 138935076
• Report Number: 2029214-2019-00217
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00847536008038
• UDI-Public: 00847536008038
• 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,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2020
• Device Model Number: 41064-01
• Device Catalogue Number: 41064-01
• Device Lot Number: A464611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR