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

Model Number	FG15150-0615-1S
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	07/17/2019
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 information that pipeline flex embolization device felt resistance in the phenom catheter and pipeline pierced/punctured the hub and is partially deployed outside of the microcatheter inner lumen.The phenom catheter broke at the proximal part.It was confirmed that the phenom catheter broke near the hub and the pipeline came out from the broken location.The issue was caused by resistance from the catheter.The patient underwent embolization treatment for an unruptured saccular aneurysm located in right internal carotid artery.It was reported that upon delivery of the ped into the phenom microcatheter the implanter felt mild resistance, nothing that hasn't been felt in previous cases.He continued to push when he realized that the ped had pierced the phenom and was being deployed outside of the inner lumen of the mc.He then removed the entire mc and ped delivery system and set aside for return to medtronic.A new ped (425-16) chosen along with a new phenom27 and case resumed without incident.There were not any patient symptoms or complications associated with this event.Yes, dapt (dual antiplatelet treatment) was administered.No images available for review.The pipeline and any accessory devices were prepared as indicated in the ifu.No patient injury was reported.Yes, the catheter flushed continuously with heparinized saline.The pushwire was not damaged.

• 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: 8875035
• Report Number: 2029214-2019-00823
• Device Sequence Number: 14109574
• Product Code: KRA
• UDI-Device Identifier: 00814584028981
• UDI-Public: 00814584028981
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

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: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: OC18-046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1