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

Model Number	FG15150-0630-1S
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that resistance was felt when pushing past the first bend in the ica, resulting in the pipeline becoming stuck.As a result the phenom and pipeline were removed together, during which it was discovered that the catheter had split/separated in the distal end.The devices were replaced and the procedure completed without further issue.The patient was undergoing surgery for an unruptured, saccular left ica aneurysm with a neck diameter of 4.2mm.It was noted that the vessel tortuosity was minimal.The devices were prepared per the ifu.There was no friction during delivery, no force was applied, the catheter tip was not stuck.Ancillary devices include a neuron max sheath.
Additional Manufacturer Narrative
H3: the pipeline flex pusher stuck inside the phenom catheter, were returned inside of a biohazard bag and a shipping box.For further examination, the pipeline flex was pushed out from the catheter lumen with difficulty.The phenom catheter appeared to be broken into two segments.When compared to the drawing the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The outer diameter (o.D) of the re-sheathing pad was measured within specifications (~0.5835mm).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 no damage.Kinks and bends found on the pusher at 14.0cm to 23.0cm from the proximal end.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.The total and usable lengths of the phenom catheter were measured to be within specifications.The catheter tip and the marker band were examined; and no damages were found.The catheter body was found to be stretched and accordioned at 14.5cm to 26.5cm from the distal tip.In addition, the catheter body appeared to be separated at 23.5cm from distal tip.The broken ends of the catheter exhibited with stretching, necking, accordioning and broken braids which indicated that the catheter separated when exceeding the tensile strength of the tubing material.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 tip and hub.The mandrel could pass through the catheter tip and hub with no issues; however, resistance was observed at the damaged locations.No other anomalies were observed.Based on the analysis findings, the pipeline flex and phenom catheter were confirmed to have resistance during delivery and catheter separation issues.The returned pipeline flex was stuck inside the broken catheter.The broken ends of the catheter exhibited with stretching, necking, accordioning and broken braids; which indicated that the catheter separated when exceeding the tensile strength of the tubing material.Additionally, the pipeline flex and catheter were to be damaged.From the damages seen on the catheter body (stretching, accordioning, separating), pushwire (kinking/bending) and hypotube (stretching); it appears there was high force used (pushing and pulling).It is likely these damages occurred when the customer attempted to advance the pipeline flex through the phenom catheter against resistance.However, the cause for resistance could not be determined.Possible causes of the resistance during delivery include patient tortuous anatomy and lack of continuous flush with heparinized saline during delivery.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.There was no non-conformance to specifications identified that led to the resistance during delivery and catheter separation issues.Per our instructions for use (ifu): ¿it is recommended to use a heparinized saline drip to continuously flush micro catheter during pipeline flex embolization device use.Discontinue delivery of the device if high force or excessive friction is encountered.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
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8753932
• Report Number: 2029214-2019-00665
• Device Sequence Number: 16625810
• Product Code: KRA
• UDI-Device Identifier: 00814584029001
• UDI-Public: 00814584029001
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: FG15150-0630-1S
• Device Catalogue Number: FG15150-0630-1S
• Device Lot Number: OC18-062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1