MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA

Model Number FG19120-1030-1S

Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

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

Event Date 08/02/2021

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 the phenom plus catheter experienced resistance in the distal part of the guide catheter and separated.The patient was undergoing onyx embolization treatment in the middle meningeal artery.The vessel tortuosity was moderate.The access vessel was the the femoral artery, which was 5mm in diameter.It was reported that the phenom plus catheter would not travel through the benchmark guide catheter, and the distal end of the phenom catheter ripped and became detached.The guide catheter appeared very flattened, which was thought to be the reason for the detachment.It was noted that the there was friction/difficulty during injection, and force had been applied during delivery/removal.The catheter tip was entrapped/stuck, and there was no vasospasm.No further medical or surgical intervention was required. the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a penumbra benchmark.071 guide catheter and an apollo microcatheter.

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

Additional information was received on 2021-08-09.It was reported that the onyx had not been injected when the catheter separated.

Manufacturer Narrative

H3.Product analysis: the phenom plus catheter, apollo microcatheter and non-medtronic penumbra benchmark.071 guide catheter were returned for analysis within shipping box; and within a plastic bag.Upon visual inspection, no damages or irregularities were found with the phenom plus hub.The phenom plus catheter body was found to be kinked at ~109.0cm from catheter hub.The phenom plus distal marker/tip appeared to be broken and separated.In addition, the separated distal marker/tip was not returned; therefore, any contributing factors (such as damage) could not be assessed.No damages were found with the apollo hub.No bends or kinks were found with the apollo catheter body.The apollo detachable tip was found intact.No damages were found with the apollo distal marker/tip.No damages were found with non-medtronic penumbra benchmark.071 guide catheter hub and body.The non-medtronic penumbra benchmark.071 guide catheter distal tip appeared to be flattened.No other anomalies were observed.The total and usable lengths of phenom catheter was not within specifications.The phenom plus catheter was flushed, water exited from distal tip.The phenom plus catheter was tested with an in-house mandrel.The mandrel successfully passed through the catheter hub and tip with no issues.The apollo total and usable lengths were measured to be within specification and the distal floppy segment length was measured to be within specification.Based on the device analysis and reported information, the customer¿s report of ¿resistance in guide catheter¿ could not be confirmed as an in-house mandrel was used for resistance testing with no issues and no resistance felt.However, the catheter separation/break was confirmed as the distal tip/marker band was found to be separated and the root cause could not be determined.There was no non-conformance to specifications identified that led to the resistance issue.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
• 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: 12294521
• MDR Text Key: 267438913
• Report Number: 2029214-2021-00990
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00763000399733
• UDI-Public: 00763000399733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2024
• Device Model Number: FG19120-1030-1S
• Device Catalogue Number: FG19120-1030-1S
• Device Lot Number: 221459990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2021
• 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
• Patient Sex: Female