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

Model Number	FG15150-0615-1S
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For further examination, the pusher was pushed out from the catheter lumen with difficulty.The pipeline flex with shield braid was not returned as it was implanted in the patient.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 ~0.5840mm.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.Kinks and bends found on the pusher at 14.0cm to 58.0cm 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 appeared to be separated at 8.5cm from the proximal end of the hub.The broken ends of the catheter exhibited with stretching, necking, according and broken braids which indicated that the catheter separated when exceeding the tensile strength of the tubing material.The catheter body found to be a cordioned from 9.0cm to 18.5cm from the distal tip; and 6.5cm to 18.5cm from the proximal end of the hub.No flash or voids molded were observed in the hub.The catheter was flushed with water and water exited out from the catheter tip.A moderate amount of dried blood observed inside of the catheter lumen.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 phenom catheter were confirmed to have catheter separation.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.The returned pipeline flex pusher was stuck inside the catheter lumen.The pusher and catheter were severely damaged.From the damages seen on the catheter body (stretching, accordioning), proximal wire (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/recapture the pipeline flex with shield through the phenom catheter against resistance.The customer reported that there was high resistance during delivery.In addition, force was applied during delivery and removal.It is possible that the patient vessel tortuosity may have contributed to the reported issues.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the phenom catheter¿s proximal end broke during the procedure.During a pipeline flex with shield embolization, the pipeline was deployed at terminal ica.Resistance in pusher wire noted at proximal deployment.Increasing tensionon phenom catheter required to balance force on delivery wire.Phenom catheter hub snapped off at junction with the blue part of the catheter.Force was applied during delivery and removal.The catheter was not trapped and there was no vasospasm.The catheter was not stuck in the guide catheter.The catheter and the separated piece will be returned for analysis.No patient injury reported.The anatomy was moderate in tortuosity.It was reported that pipeline device was implanted at intended location.Yes, the continuous flush administered during the procedure.

• Brand Name: CATHERA
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10677101
• Report Number: 2029214-2020-01028
• Device Sequence Number: 19635412
• Product Code: KRA
• UDI-Device Identifier: 00814584028981
• UDI-Public: 00814584028981
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: 04/30/2021
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: MY18-062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 60