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

Model Number FG15160-0615-1S

Device Problems Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

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

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

H3: product analysis of fg15160-0615-1s, lotno:226724217 found no damages with the phenom 27 catheter hub.No bends or kinks were found with the phenom 27 catheter body.The phenom 27 catheter distal tip was found to be in good condition.The catheter total and usable length were measured within specifications.The phenom 27 catheter was flushed, water exited from the distal tip.An in-house 0.026¿ mandrel was inserted into the phenom 27 catheter hub; however, resistance was encountered at ~10.5cm from the proximal end of hub.The in-house mandrel was then inserted into the catheter distal tip.Resistance was encountered at ~11.5cm from the proximal end of hub.The phenom 27 catheter was dissected at the resistance location.The catheter inner liner was found damaged at ~10.5cm to 11.5cm from the proximal end of the catheter hub.Based on the device analysis and reported information, the customer¿s ¿catheter resistance at hub¿ report was confirmed.In this event, it is likely the damage found with the phenom 27 catheter inner liner contributed to the reported event.However, the cause for the catheter liner damage could not be determined.Since the pipeline flex shield was not returned; any contribution of the pipeline flex shield to the reported issue 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.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 a report that after the pipeline was flushed, the pipeline was delivered into the phenom27, but there was a resistance at the point where the pipeline was about to go over the hub, so it was determined that the pipeline was defective.The same action was tried again, but there was still resistance.Suspecting a problem with the phenom27, the phenom27 was replaced.The phenom27 was delivered smoothly, so the procedure was continued.The pipeline was not used for an off-label use.The pipeline and any accessories were prepared as indicated in the instructions for use (ifu).The phenom27 was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, unruptured right internal carotid artery (ica) aneurysm with a max d iameter of 7mm and a 4mm neck diameter.The landing zone artery size measurements were 25mm distally and 4.3mm proximally.The access vessel was the ica with a diameter of 4mm.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (d apt) was administered.The post procedure angiographic result showed no particular problems.The sheath tip was firmly positioned in the hub.

• 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: 18631895
• MDR Text Key: 334753590
• Report Number: 2029214-2024-00226
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• 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: 226724217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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