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

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	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition: the pipeline flex w/ shield device and phenom-27 micro catheter were returned for analysis within a shipping box; within an opened pipeline flex w/ shield outer carton; within an opened pipeline flex w/ shield inner pouch and within a dispenser coil.Visual inspection/damage location details: no damages or irregularities were found with the phenom-27 catheter hub.Dried blood, the pipeline flex w/ shield braid and distal delivery wire was found stuck within the hub.The phenom-27 micro catheter was found broken at ~55.5cm from the proximal end.The edge of the break was found smooth, and the inner wire was found cleanly broken at the same location.It is likely the catheter was cut.The distal segment of the micro catheter was not returned for analysis.The catheter was destroyed to extract the pipeline flex w/ shield device.The distal pusher delivery wire was found broken between the resheathing pad and the ptfe dps sleeves.The proximal segment of the pusher was not returned for analysis.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The tip coil was found damaged.The proximal braid end was found not opened, damaged, and frayed.The middle and distal braid were found fully opened.The distal end was found damaged and frayed.Testing/analysis: the phenom-27 inner diameter, total length and usable length could not be measured as the partial device was destroyed during the extraction of the pipeline.The separated distal wire was sent out for sem testing.Conclusion: based on the analysis findings, the customer report of ¿failure/incomplete open at middle section (hourglass shape)¿ could not be confirmed.Possible causes for incomplete open during the procedure are patient vessel tortuosity, damaged braid, braid improperly size to anatomy, braid overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents or inappropriate anatomy.The braid was found damaged.Potential causes for braid damage are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/resheathing braid against resistance, or damage during return shipping as the braids were returned already deployed and out of its protective introducer sheaths and dispenser coils.Customer reported pipeline was resheathed 2 or less times, all devices were prepared per ifu, and patient vessel tortuosity as severe.Customer report of device ¿stuck in catheter hub¿ was confirmed as the device returned separated and stuck within the hub, however, the cause could not be determined.It is possible the braid became damaged during the procedure which caused the braid to not properly be resheathed during extraction and cause the distal wire to break.Sem results: ¿the wire f ailed via tortional overload.¿ there is no indication that the event is related to a potential manufacturing issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a pipeline flex with shield that failed to open in the middle and then became stuck and deployed in the hub of the phenom microcatheter.The patient was undergoing a procedure to treat an unruptured saccular aneurysm of the left internal carotid artery (ica) cavernous segment.The aneurysm max diameter was 11mm and the neck diameter was 7mm.Vessel tortuosity was severe.Dual antiplatelet treatment (dapt) was administered.It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).During deployment, the middle section of the pipeline was not opening.Resheathing was tried but the pipeline still did not open.It was noted the middle of the pipeline was positioned in the vessel cavernous bend.The pipeline was resheathed 2 or less times.When resheathing into the delivery sheath, the pipeline got stuck in the phenom catheter hub and deployed in the catheter hub.The device was removed and a competitor's device was then used to complete the procedure.There were no patient symptoms or complications associated with the event.Post-procedure angiography was uneventful.

• Brand Name: CATHERA
• 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: 12964621
• Report Number: 2029214-2021-01583
• Device Sequence Number: 4389468
• Product Code: DQY
• UDI-Device Identifier: 00847536041868
• UDI-Public: 00847536041868
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other
• 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: 11/30/2023
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: DE20-031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 60 KG