MAUDE Adverse Event Report: CATHERA, INC. PHENOM; CATHETER, CONTINUOUS FLUSH

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Vascular Dissection (3160)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

The phenom microcatheter device was not returned; therefore, product analysis of the device was not able to be performed.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure and patient condition related event.Clot formation is a known inherent risk of endovascular procedure and is documented in the phenom microcatheter instructions for use (ifu).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during the treatment of a brain aneurysm, a dissection was identified prior to the used of any medtronic device.Follow up image after successful placement of the pipeline flex with shield, there was note of a non-flow limiting clot, and the small dissection was now noted to have an intimal flap.The intimal flap did not cause flow limitations but was treated with a solitaire stent.Through a long destination 6f guiding sheath inserted in the right internal carotid artery (ica), a fargo max distant guiding catheter was inserted into the distal cervical part of the ica.A slight excess filling indicating a small dissection was observed, which did not cause a disturbance in flow.Following diagnostic angiographies, using the catheter we first attempted to insert a microcatheter into the distal ica next to the aneurysm.Despite all our efforts, this proved unsuccessful.The microcatheter was therefore replaced, which we likewise attempted to insert in a distal position from the aneurysm with a guidewire.However, this also proved to be impossible.Eventually they were able to reach the distal ica from a reverse direction by making a loop inside the aneurysm with the micro-catheter positioned inside the aneurysm, and to insert the micro-catheter as far as the m2 segment of the middle cerebral artery.However, it could not be inserted further, because it proved impossible to move the catheter into a more distal position.However, in this case the microcatheter was not long enough.From this catheter position we attempted to straighten the microcatheter looped inside the aneurysm, but the attempt was unsuccessful due to the shortness of the microcatheter.After checking the position of the catheter on the neck, a break was observed at the insertion end of the long catheter.We were thus obliged to remove h entire system.New devices were selected.A new microcatheter was able to successfully deliver a pipeline (ped).The ped¿s distal end was positioned at the level of the expected origin of the posterior communicating artery, while its proximal end was positioned in the horizontal segment of the carotid siphon.The angiograms, the position of the stent was satisfactory throughout.A follow-up angiogram indicated slowed circulation in the aneurysm, and perfect circulation in the ica.In the right frontal distal branch of the middle cerebral artery, intracranial circulation was slightly slowed, and signs of thrombus formation were observed, although circulation was maintained throughout.Proximally, in the cervical area, in keeping with the small dissection that was observed earlier, a relatively more extended dissection with intimal flap was observed, which did not cause a disturbance in flow.Nevertheless, a 6 x 30 mm solitaire stent was positioned here in order to prevent a possible progressive occlusion.The patient was reported to have been discharged on the same day of the procedure.The saccular aneurysm was in the right ica (c6).The max diameter was 15.7mm with a dome height of 3.7mm and width of 12.7mm.The neck was 7.7mm, the distal parent artery was 2.1 and the proximal was 3.8mm.Baseline mrs was 5 (13apr2018).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PHENOM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): CATHERA, INC.; 627 national ave.,; mountain view CA 94043
• Manufacturer (Section G): CATHERA, INC.; 627 national ave.,; mountain view CA 94043
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7690253
• MDR Text Key: 114057406
• Report Number: 2029214-2018-00625
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: D260458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR