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

Model Number	FG15150-0615-1S
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline experienced resistance in the distal part of the phenom 27 catheter. the catheter was replaced, and the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).The patient's vessel tortuosity was moderate.The access vessel was 7mm in diameter.Additional information was received.The proximal end of the ped push rod (40-50 from the extreme end) was kinked, but the degree of kink was moderate.The surgeon said that the stent was not damaged and was successfully implanted.
Additional Manufacturer Narrative
The phenom-27 catheter was returned in 3 segments.The phenom catheter 1st segment was found to be separated at proximal end of hub.The 2nd segment total length was measured to be ~112.9cm and the 3rd segment total length was measured to be 41.4cm.No damages were found with the phenom hub itself.The phenom 27 catheter body separated 3rd distal segment was found to be kinked at ~9.9cm, at ~3.0cm and at ~0.9cm from distal tip.No damages or irregularities were found with the distal marker/tip.The phenom 27 catheter was flushed; water exited from the distal tip.The 3 segments of the phenom-27 catheter were then tested with an in-house 0.026¿ mandrel.The mandrel exited each segment without issue.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was unable to be confirmed and the root cause was unable to be determined.Possible causes for ¿catheter resistance¿ are continuous flush rate too low, catheter or delivery system damage or insufficient delivery system hydration.It is possible the damage (kinked) found with the catheter body contributed to the resistance.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
• 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: 12965200
• Report Number: 2029214-2021-01584
• Device Sequence Number: 4533713
• Product Code: KRA
• UDI-Device Identifier: 00847536041868
• UDI-Public: 00847536041868
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: MY20-020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female