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

Model Number FG15150-0615-1S

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 12/17/2020

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 pipeline was stuck in the phenom 27 microcatheter.The catheter stretched and when pulled back to get the pipeline out, the catheter came apart/separated at the distal tip.It was noted force was applied during the delivery or removal, a continuous flush had been used, and the physician released the load in the system in an attempt to resolve the issue but it did not.There was no damage to the pipeline pushwire.It was indicated that all devices were prepared as per the instructions for use (ifu), and there was no patient injury or medical/surgical intervention reported at the time of the event.The patient's vessel tortuosity was severe.Ancillary devices include a rist 71 phenom 27.

Manufacturer Narrative

H3: the pipeline flex was returned stuck within the distal segment of the phenom 27 catheter.The pipeline flex could not be pushed forward or removed.For further examination, the phenom 27 catheter was cut to remove the pipeline flex.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.Bends were found at 22.5cm to 49.0cm from the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the phenom 27 catheter were measured to be within specifications.The catheter distal marker band appeared be broken and missing from the catheter.The reason for not returning was provided.The catheter body was found to be flattened at 1.0cm to 28.0cm from the distal tip.No flash or voids molded were observed in the hub.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter hub.The mandrel successfully passed through the catheter hub; however, resistance was observed at the damaged locations.No other anomalies were observed.Based on the returned devices, the pipeline flex and phenom 27 catheter were confirmed to have ¿resistance during delivery¿, ¿catheter resistance¿ and ¿catheter separation¿ issues as the returned pipeline flex was found stuck inside the distal segment of the phenom catheter.In addition, the distal marker band were separated and missing from the catheter.From the damages seen on the catheter distal marker band (separating), catheter body (flattening), pushwire (bending), pipeline flex braid (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance/retrieve the pipeline flex through the phenom catheter against the resistance.It is likely that the severe vessel tortuosity may have contributed to the reported issues.There was no non-conformance to specifications identified that led to the reported issues.In addition, the review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Since the distal marker band was not returned; any contribution of the marker band to the reported issues could not be determined.Per our instructions for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ 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
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11056587
• MDR Text Key: 225565316
• Report Number: 2029214-2020-01357
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536041868
• UDI-Public: 00847536041868
• Combination Product (y/n): N
• PMA/PMN Number: K151638
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: MA20-062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1