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

Model Number	FG15150-0630-1S
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex embolization device (model: ped-450-16 lot: a415966) and phenom 27 catheter (model: fg15150-0630-1s lot: oc18-006) were returned for analysis within a shipping box; within a secondary shipping box; within an opened pipeline flex outer carton and within an opened phenom 27 inner pouch.The pipeline flex embolization device was returned outside the phenom 27 catheter.The phenom 27 catheter was returned separated into two segments.The pipeline flex pushwire was found bent at ~23.0cm from the proximal end.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The proximal bumper, re-sheathing pad, distal marker and ptfe sleeves were found to be in good condition.No bends or kinks were found with the tip coil.The braid was not returned.The reason for the brain not returning was not provided.The phenom 27 catheter proximal segment total length was measured to be ~120.9cm and the distal segment total length was measured to be ~29.2cm (useable length specification: 150cm ± 5cm).No bends or kinks were found with the phenom 27 catheter proximal segment.The phenom 27 proximal segment distal separated end exhibited with plastic deformation (jagged edges and stretching) with the inner wire broken and exposed.The phenom 27 catheter proximal segment was then tested by running an in-house 0.026¿ mandrel.The in-house mandrel passed through the phenom 27 catheter proximal segment with resistance exiting the separated end.The phenom 27 catheter distal segment was found kinked at ~24.2cm, 16.0cm and 3.0cm from the distal tip.No damages or irregularities were found with the phenom 27 distal marker/tip.The phenom 27 catheter distal segment was then tested by running an in-house 0.026¿ mandrel.The in-house mandrel passed through the phenom 27 catheter distal segment with resistance at the kinked locations.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s reports of ¿lockup/resistance at distal segment of catheter¿ could not be confirmed as the pipeline flex embolization device was returned outside the phenom 27 catheter.It is possible that the patients ¿severely¿ tortuous anatomy may have contributed to the reported issues.Regarding the customer¿s report of ¿catheter kink/damage¿ the issue was confirmed.However, the cause for the kinks found with the catheter could not be determined.The returned phenom 27 catheter was found separated into two segments.A broken end of the catheter exhibited with plastic deformation which indicated that the catheter separated when exceeding the tensile strength of the tubing material.It appears there was high force used (pushing and pulling) against resistance.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that one phenom catheter broke.Second pipeline stuck within the phenom 027 catheter.The patient underwent embolization treatment for a medium unruptured amorphous internal carotid artery aneurysm, measuring 15mm, landing zone distal 4.2mm, proximal 4.25mm.The vessel was observed severely tortuous.It was reported that first pipeline flex (lot number a324633) advanced into phenom catheter (lot number 0c18-062).Phenom catheter broke distally.Pipeline flex and phenom were then removed as a unit from the patient.There was not any friction or difficulty during delivery.Yes, there force applied during delivery or removal.There was not any vasospasm.The catheter was flush with heparinized saline.(10, 30) it was reported that second pipeline flex advanced into phenom 027.Attempted to un-sheath the pipeline flex tip coil.Pipeline flex appeared to be stuck within the phenom 027.Pipeline flex tip coil could not be un-sheathed, nor could the pipeline flex be further advanced from the phenom 027.Both phenom 027 and pipeline flex (lot number a415966) were removed as a unit.The catheter was flushed continuously with heparinized saline.The catheter was damaged.(pli 20, 40) there was not any patient symptoms or complications associated with this event.Yes, dapt (dual antiplatelet treatment) was administered.No patient injury was reported.The pipeline and any accessory devices were prepared as indicated in the ifu.6f neuron max 088 penumbra, 4 max ddc, synchro.

• Brand Name: CATHERA
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8688325
• Report Number: 2029214-2019-00542
• Device Sequence Number: 2472861
• Product Code: KRA
• UDI-Device Identifier: 00814584029001
• UDI-Public: 00814584029001
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2019

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: OC18-006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1